General Hospital (HO) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the General Hospital (HO) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 868, Part 878, Part 880

Subparts

Part 868 Subpart F—Therapeutic Devices — 1 product code
Part 878 Subpart E—Surgical Devices — 2 product codes
Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices — 34 product codes
Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices — 165 product codes
Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices — 119 product codes

Product Codes

Product Code	Device Name	Regulation	Class	Devices
QFB	Isocapnic Ventilation Device	868.5480	2	1
GAG	Stapler, Surgical	878.4740	2	42
QQS	Stapler, Skin	878.4740	1	0
KPD	Strip, Temperature, Forehead, Liquid Crystal	880.2200	2	21
KMI	Monitor, Bed Patient	880.2400	1	31
PJO	Fall Prevention Alarm/Sensor Combination Attached Or Unattached	880.2400	1	0
PJP	Fall Prevention Alarm/Sensor Attached Only	880.2400	1	0
SBO	Bed-Patient Activity Monitoring System	880.2400	1	1
FLN	Monitor, Electric For Gravity Flow Infusion Systems	880.2420	2	39
CAR	Monitor, Spinal-Fluid Pressure, Electrically Powered	880.2460	2	3
FMJ	Manometer, Spinal-Fluid	880.2500	2	6
FRI	Scale, Stand-On, Patient	880.2700	1	3
FRW	Scale, Patient	880.2720	1	48
FQA	Scale, Surgical Sponge	880.2740	1	1
LWH	Counter, Sponge, Surgical	880.2740	1	15
MRL	Scale, Sponge, Surgical, Electrically-Powered	880.2740	1	1
PBZ	Image Processing Device For Estimation Of External Blood Loss	880.2750	2	6
FRC	Indicator, Biological Sterilization Process	880.2800	2	206
JOJ	Indicator, Physical/Chemical Sterilization Process	880.2800	2	265
LRT	Indicator, Sterilization	880.2800	2	5
MRB	Indicator, Biological, Liquid Chemical Sterilization Process	880.2800	2	4
MTC	Indicator, Chemical, Enzymatic, Sterilization Process	880.2800	2	2
OCI	Indicator, Physical/Chemical, Storage Temperature	880.2800	2	1
QKM	A Chemical Vapor Sterilization Multivariable Chemical Indicator	880.2800	2	5
SBE	Digital Physical/Chemical Sterilization Process Sensor	880.2801	2	0
OWP	Biological Sterilization Process Indicator With Recombinant-Dna Plasmid	880.2805	2	5
QVB	Biological Sterilization Indicator With Indirect Growth Detection	880.2806	2	1
FQZ	Thermometer, Clinical Color Change	880.2900	1	14
FLL	Continuous Measurement Thermometer	880.2910	2	797
OZK	Thermometer, Exhaled Breath	880.2910	2	0
PWW	Fever Monitoring Kit	880.2910	2	0
PXH	Thermometer Kit	880.2910	2	0
SDV	Clinical Electronic Thermometer	880.2910	2	0
SDW	Stationary Infrared Thermometer	880.2910	2	0
QZA	Body Temperature Sensing Software	880.2915	2	2
FLK	Thermometer, Clinical Mercury	880.2920	2	33
LHB	Timer, Apgar	880.2930	1	2
KPE	Container, I.V.	880.5025	2	117
FRF	Cleaner, Air, Medical Recirculating	880.5045	2	53
NUP	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier	880.5045	2	8
FQM	Bandage, Elastic	880.5075	1	42
MCY	Wound Dressing Kit	880.5075	2	24
MHW	Dressing, Compression	880.5075	1	2
OXQ	Dressing Change Tray	880.5075	1	0
KMF	Bandage, Liquid	880.5090	1	222
NEC	Bandage, Liquid, Skin Protectant	880.5090	1	3
FNL	Bed, Ac-Powered Adjustable Hospital	880.5100	2	70
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	880.5100	2	2
OSI	Bariatric Bed	880.5100	2	0
FNK	Bed, Hydraulic, Adjustable Hospital	880.5110	1	1
FNJ	Bed, Manual	880.5120	1	39
FMT	Warmer, Infant Radiant	880.5130	2	92
ONM	Radiant Infant Warmer Cabinet	880.5130	2	0
FMS	Bed, Pediatric Open Hospital	880.5140	2	27
NZG	Bassinet, Hospital	880.5145	2	0
IKY	Mattress, Flotation Therapy, Non-Powered	880.5150	1	8
QVY	Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome	880.5151	2	1
FQK	Binder, Perineal	880.5160	1	0
FSD	Binder, Abdominal	880.5160	1	5
HEF	Binder, Breast	880.5160	1	0
KMO	Binder, Elastic	880.5160	1	5
MDR	Binder, Medical, Therapeutic	880.5160	1	0
FPY	Sheet, Burn	880.5180	1	17
FOS	Catheter, Umbilical Artery	880.5200	2	34
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	880.5200	2	503
LRS	I.V. Start Kit	880.5200	2	30
NGT	Saline, Vascular Access Flush	880.5200	2	41
NZW	Heparin, Vascular Access Flush	880.5200	2	7
NZX	Water, Vascular Access Flush	880.5200	2	0
OWL	Peripheral Catheter Insertion Kit	880.5200	2	0
PEF	Heparin Flush In 0.45% Sodium Chloride	880.5200	2	0
PEZ	Central Venous Catheter Dressing Change Kit	880.5200	2	0
PND	Midline Catheter	880.5200	2	13
PXJ	Umbilical Catheter Insertion Tray	880.5200	2	0
QTI	Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device	880.5200	2	1
SEF	Central Venous Catheter With Manual Insertion System	880.5200	2	1
KMK	Device, Intravascular Catheter Securement	880.5210	1	64
PUK	Administration Set Securement Device	880.5210	1	0
QOI	Intravenous Catheter Force-Activated Separation Device.	880.5220	2	8
FPX	Strip, Adhesive, Closure, Skin	880.5240	1	35
KGX	Tape And Bandage, Adhesive	880.5240	1	187
MZR	Topical Approximation System	880.5240	1	0
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	880.5240	1	1
FOK	Pad, Neonatal Eye	880.5270	1	5
FRL	Fiber, Medical, Absorbent	880.5300	1	19
FMZ	Incubator, Neonatal	880.5400	2	85
QWX	Active Noise Attenuation System For Infant Incubators	880.5405	2	1
FPL	Incubator, Neonatal Transport	880.5410	2	25
KZD	Infusor, Pressure, For I.V. Bags	880.5420	1	35
KZE	Injector, Fluid, Non-Electrically Powered	880.5430	2	53
BRZ	Set, Blood Transfusion	880.5440	2	30
CAK	Microfilter, Blood Transfusion	880.5440	2	36
FMG	Stopcock, I.V. Set	880.5440	2	89
FPA	Set, Administration, Intravascular	880.5440	2	1174
FPB	Filter, Infusion Line	880.5440	2	98
FPK	Tubing, Fluid Delivery	880.5440	2	64
LHI	Set, I.V. Fluid Transfer	880.5440	2	205
MJF	Check Valve, Retrograde Flow (In-Line)	880.5440	2	1
NEP	System/Device, Pharmacy Compounding	880.5440	2	0
ODI	Administration Set Docking Station	880.5440	2	1
OJA	Intravenous Extension Tubing Set	880.5440	2	1
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	880.5440	2	41
POQ	Blood Transfusion Kit	880.5440	2	0
POR	Parenteral Administration Kit	880.5440	2	0
PQH	Iodinated Contrast Media Transfer Tubing Set	880.5440	2	5
PWH	Administrations Sets With Neuraxial Connectors	880.5440	2	4
PWO	Blood Administration Kit	880.5440	2	0
PWQ	Buret Administration Intravenous Kit	880.5440	2	0
PYR	Neuraxial Administration Set - Intrathecal Delivery	880.5440	2	0
QBP	Cap, Device Disinfectant	880.5440	2	22
OKL	Intravascular Administration Set, Automated Air Removal System	880.5445	2	2
FRR	Chamber, Reverse Isolation, Patient Care	880.5450	2	1
LGM	Chamber, Patient Isolation	880.5450	2	12
LGN	Chamber, Patient Transport Isolation	880.5450	2	2
FQH	Lavage, Jet	880.5475	2	53
FNG	Lift, Patient, Ac-Powered	880.5500	2	21
FSA	Lift, Patient, Non-Ac-Powered	880.5510	1	13
FNM	Mattress, Air Flotation, Alternating Pressure	880.5550	2	102
FOH	Mattress, Water, Temperature Regulated	880.5560	1	6
FMI	Needle, Hypodermic, Single Lumen	880.5570	2	689
MHC	Needle, Interosseous	880.5570	2	2
MMK	Container, Sharps	880.5570	2	112
NKK	Needle, Hypodermic, Single Lumen, Reprocessed	880.5570	2	0
PTI	Non-Coring (Huber) Needle	880.5570	2	13
PVZ	Non-Stainless Steel Needle	880.5570	2	1
PWY	Lumbar Puncture Tray (Adult & Pediatric)	880.5570	2	0
PXB	Percutaneous Introducer Kit	880.5570	2	0
PXI	Thoracentesis Tray	880.5570	2	0
PXL	Venipuncture Kit	880.5570	2	0
QMT	Prep Kit Vaccine Injection	880.5570	2	0
QNS	Low Dead Space Needle, Single Lumen, Hypodermic	880.5570	2	3
QYM	Ophthalmic Needle	880.5570	2	2
SCL	Allergen And Vaccine Delivery Needles	880.5570	2	25
BWJ	Locator, Acupuncture Point	880.5580	2	3
MQX	Needle, Acupuncture, Single Use	880.5580	2	91
NRW	Stimulator, Intramuscular, Automatic	880.5580	2	1
HFS	Shield, Nipple	880.5630	1	12
NTC	Nursing Pad, Hydrogel	880.5630	1	1
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	880.5630	1	1
NXH	Nursing Pad, Cohesive Gel	880.5630	1	1
FNN	Nipple, Lambs Feeding	880.5640	1	0
FRP	Holder, Infant Position	880.5680	1	14
OUW	Infant Positioner, Rx, Use In Highly Monitored Setting	880.5680	1	1
PRN	Pediatric Position Holder	880.5680	1	0
QTG	Infant Supine Sleep System	880.5690	2	1
LBI	Unit, Neonatal Phototherapy	880.5700	2	71
PDH	Blanket, Neonatal Phototherapy	880.5700	2	2
PWN	Baby Care Kit	880.5700	2	0
FRN	Pump, Infusion	880.5725	2	848
LDR	Controller, Infusion, Intravascular, Electronic	880.5725	2	60
LGZ	Warmer, Thermal, Infusion Fluid	880.5725	2	74
LHF	Warmer, Microwave, Infusion Fluid	880.5725	2	2
LZF	Pump, Infusion, Analytical Sampling	880.5725	2	7
LZG	Pump, Infusion, Insulin	880.5725	2	84
LZH	Pump, Infusion, Enteral	880.5725	2	33
MEA	Pump, Infusion, Pca	880.5725	2	31
MEB	Pump, Infusion, Elastomeric	880.5725	2	87
MHD	Pump, Infusion, Gallstone Dissolution	880.5725	2	1
MRH	Pump, Infusion, Ophthalmic	880.5725	2	19
MRZ	Accessories, Pump, Infusion	880.5725	2	48
OPP	Pump, Infusion, Insulin Bolus	880.5725	2	7
PHC	Infusion Safety Management Software	880.5725	2	10
PKP	Immunoglobulin G (Igg) Infusion System	880.5725	2	7
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	880.5725	2	5
QJY	Infusion Pump, Drug Specific, Pharmacy-Filled	880.5725	2	4
QXC	Diabetes Digital Therapeutic Device	880.5735	2	1
KYP	Snake Bite Suction Kit	880.5740	1	4
PWX	Insect Sting Emergency Kit	880.5740	1	0
KYQ	Kit, Chemical Snake-Bite	880.5760	3	0
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	880.5780	2	64
FQL	Stocking, Medical Support (For General Medical Purposes)	880.5780	1	6
LLK	Legging, Compression, Non-Inflatable	880.5780	2	4
FQJ	Support, Scrotal, Therapeutic	880.5820	1	0
FMF	Syringe, Piston	880.5860	2	749
MEG	Syringe, Antistick	880.5860	2	163
MZM	Fibrin Sealant Preparation Device	880.5860	2	0
NKN	Syringe, Piston, Reprocessed	880.5860	2	0
NSC	Injector, Pen	880.5860	2	1
PQX	Epinephrine Syringe	880.5860	2	2
PUR	Vacuum Syringe	880.5860	2	2
QBL	Piston Syringe Lever	880.5860	2	3
QDM	Midazolam Syringe	880.5860	2	0
QEH	Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact	880.5860	2	5
QLF	On-Body Injector	880.5860	2	0
QLY	Ophthalmic Syringe	880.5860	2	7
QNQ	Low Dead Space Piston Syringe	880.5860	2	12
QOG	Injection Data Capture Device	880.5860	2	7
FOD	Device, Occlusion, Umbilical	880.5950	1	0
LJL	Detectors And Removers, Lice, (Including Combs)	880.5960	1	11
PUN	Lice Removal Kit Containing A Solution	880.5960	1	0
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	880.5965	2	287
LLD	Port & Catheter, Implanted, Subcutaneous, Intraperitoneal	880.5965	2	4
OBK	Port, Protector/Cushion	880.5965	2	1
OKE	Port Introducer Kit	880.5965	2	0
PTD	Subcutaneous Implanted Apheresis Port	880.5965	2	3
PXK	Vascular Access Port Kit	880.5965	2	0
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	880.5970	2	302
ODY	Tunneled Catheter Remover	880.5970	2	2
OKC	Implanted Subcutaneous Securement Catheter	880.5970	2	5
OMF	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position	880.5970	2	2
PWR	Catheter Repair Kit	880.5970	2	0
PZW	Catheter Access Cover, Tamper-Resistant	880.5970	2	2
KXF	Applicator, Absorbent Tipped, Non-Sterile	880.6025	1	21
KXG	Applicator, Absorbent Tipped, Sterile	880.6025	1	1
KYR	Bag, Ice	880.6050	1	4
KME	Bedding, Disposable, Medical	880.6060	1	65
FPS	Board, Bed	880.6070	1	1
FOA	Board, Cardiopulmonary	880.6080	1	3
FPF	Bottle, Hot/Cold Water	880.6085	1	1
FLI	Cabinet, Ethylene-Oxide Gas Aerator	880.6100	2	8
FML	Chair, Blood Donor	880.6140	1	2
FRJ	Chair, Geriatric	880.6140	1	0
FRK	Chair, Examination And Treatment	880.6140	1	4
KMN	Chair And Table, Medical	880.6140	1	3
FLG	Cleaner, Ultrasonic, Medical Instrument	880.6150	1	19
KIA	Cover, Cast	880.6185	1	1
FMW	Cover, Mattress (Medical Purposes)	880.6190	1	14
QTV	Mattress And Bed Deck Cover (Medical Purposes)	880.6190	1	1
FNS	Ring Cutter	880.6200	1	0
MTV	Sharps Needle Destruction Device	880.6210	2	9
FMA	Depressor, Tongue, Non-Surgical	880.6230	1	5
FMC	Patient Examination Glove	880.6250	1	34
LYY	Latex Patient Examination Glove	880.6250	1	1954
LYZ	Vinyl Patient Examination Glove	880.6250	1	799
LZA	Polymer Patient Examination Glove	880.6250	1	1168
LZB	Finger Cot	880.6250	1	5
LZC	Medical Glove, Specialty	880.6250	1	79
OIG	Powder-Free Guayle Rubber Examination Glove	880.6250	1	1
OPC	Powder-Free Polychloroprene Patient Examination Glove	880.6250	1	1
OPH	Radiation Attenuating Medical Glove	880.6250	1	0
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	880.6250	1	0
PWP	Blood Borne Pathogen Response Kit	880.6250	1	0
PWS	Chemotherapy Administration Kit	880.6250	1	0
PWT	Chemotherapy Spill Clean-Up Kit	880.6250	1	0
PWV	Delivery Room Apparel Kit	880.6250	1	0
PXC	Personal Protection Kit	880.6250	1	0
PXD	Prep Kit	880.6250	1	0
QDO	Fentanyl And Other Opioid Protection Glove	880.6250	1	0
NZJ	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies	880.6260	2	2
ORW	N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies	880.6260	2	1
FME	Gown, Examination	880.6265	1	5
KYS	Insoles, Medical	880.6280	1	1
NRV	Implantable Radio Frequency Transponder System	880.6300	2	1
PYQ	Rfid Chip For Dental Appliance	880.6300	2	1
OZW	Ingestible Event Marker	880.6305	2	8
OUG	Medical Device Data System	880.6310	1	1
NZH	Medication Management System, Remote	880.6315	2	2
SAK	Software Device To Aid In The Prediction Or Diagnosis Of Sepsis	880.6316	2	1
KZF	Device, Medical Examination, Ac Powered	880.6320	1	37
PEQ	Accessories To Examination Light	880.6320	1	1
KYT	Light, Examination, Medical, Battery Powered	880.6350	1	6
KMJ	Lubricant, Patient	880.6375	1	49
MMS	Lubricant, Vaginal, Patient	880.6375	1	0
ONK	Oral Lubricant	880.6375	1	1
KYW	Container, Liquid Medication, Graduated	880.6430	1	2
KYX	Dispenser, Liquid Medication	880.6430	1	11
OHY	Pill Crusher/Cutter	880.6430	1	0
PXA	Oral Administration Set	880.6430	1	0
FMP	Protector, Skin Pressure	880.6450	1	23
FRA	Purifier, Air, Ultraviolet, Medical	880.6500	2	36
MKB	Device, Germicidal, Ultraviolet	880.6500	2	0
QXJ	Whole Room Microbial Reduction Device	880.6510	2	2
SCS	Ultraviolet Radiation Disinfection Chamber Device	880.6511	2	2
SGX	Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves	880.6512	2	1
OSZ	Antimicrobial Keyboard	880.6600	2	1
KMG	Purifier, Water, Ultraviolet, Medical	880.6710	2	9
FNP	Urinal	880.6730	1	1
FNY	Basin, Emesis	880.6730	1	9
FOB	Bedpan	880.6730	1	5
PWM	Admission Kit (Patient Utensil)	880.6730	1	0
PWZ	Mid-Stream Collection Kit	880.6730	1	0
PXF	Sitz Bath Kit	880.6730	1	0
BYY	Tube, Aspirating, Flexible, Connecting	880.6740	2	24
BYZ	Trap, Sterile Specimen	880.6740	2	9
CBC	Bottle, Collection And Trap, Breathing System (Uncalibrated)	880.6740	2	3
CBD	Bottle, Collection, Breathing System (Calibrated)	880.6740	2	3
GAZ	Tubing, Noninvasive	880.6740	2	27
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	880.6740	2	87
JOL	Catheter And Tip, Suction	880.6740	2	84
KDP	Regulator, Vacuum	880.6740	2	21
KDQ	Bottle, Collection, Vacuum	880.6740	2	48
PAD	Chest Drainage Kit	880.6740	2	0
BRT	Restraint, Patient, Conductive	880.6760	1	0
FMQ	Restraint, Protective	880.6760	1	134
OYS	Patient Bed With Canopy/Restraints	880.6760	1	3
FRZ	Device, Patient Transfer, Powered	880.6775	2	5
FMR	Device, Transfer, Patient, Manual	880.6785	1	5
FLH	Washer Of Body Waste Receptacles	880.6800	1	0
JOK	Scissors, Medical, Disposable	880.6820	1	7
FRG	Wrap, Sterilization	880.6850	2	320
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	880.6850	2	277
QJT	Rigid Sterilization Container With Software	880.6855	2	1
FLF	Sterilizer, Ethylene-Oxide Gas	880.6860	2	26
MLR	Sterilizer, Chemical	880.6860	2	47
PJJ	Two Or More Sterilant Sterilizer	880.6860	2	6
KMH	Sterilizer, Dry Heat	880.6870	2	10
FLE	Sterilizer, Steam	880.6880	2	184
PEC	Sterilizer Automated Loading System	880.6880	2	1
LFE	Solution, Cold Sterilizing	880.6885	2	1
MED	Sterilant, Medical Devices	880.6885	2	64
QWS	Foam Or Gel Chemical Sterilant/High Level Disinfectant	880.6886	2	2
OVY	Liquid Chemical Processing System	880.6887	2	4
LRJ	Disinfectant, Medical Devices	880.6890	1	73
PWU	Clean-Up Kit	880.6890	1	0
PXG	Spill Kit	880.6890	1	0
PXM	Vomitus Clean-Up Kit	880.6890	1	0
FPP	Stretcher, Hand-Carried	880.6900	1	39
NZD	Stretcher, Patient Restraint	880.6900	1	1
FPO	Stretcher, Wheeled	880.6910	2	50
KZH	Introducer, Syringe Needle	880.6920	2	47
SDC	Qualitative Cleaning Process Protein Indicator	880.6930	2	1
KYZ	Syringe, Irrigating (Non Dental)	880.6960	1	41
OGQ	Ear Irrigation Kit	880.6960	1	0
KZA	Device, Vein Location, Liquid Crystal	880.6970	1	6
LBJ	Device, Vein Stabilization	880.6980	1	0
FOX	Stand, Infusion	880.6990	1	36
LDS	Device, Pasteurization, Hot Water	880.6991	2	11
MDZ	Cleaners, Medical Devices	880.6992	2	2
MEC	Disinfector, Medical Devices	880.6992	2	2
QXQ	Respiratory Accessory Microbial Reduction Device.	880.6993	2	2
SEW	Automated Endoscope Channel Cleaner	880.6994	2	2

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