Part 868 Subpart G—Miscellaneous
FDA submissions for Part 868 Subpart G—Miscellaneous in the Anesthesiology (AN) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 868.6100–868.6885
CFR Part: 868
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| BRY | Cabinet, Table And Tray, Anesthesia | 868.6100 | 1 | 5 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 868.6175 | 1 | 8 |
| BXJ | Clip, Nose | 868.6225 | 1 | 4 |
| BTI | Compressor, Air, Portable | 868.6250 | 2 | 74 |
| BXK | Gas, Calibration (Specified Concentration) | 868.6400 | 1 | 32 |
| BRX | Stool, Anesthesia | 868.6700 | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 868.6810 | 1 | 116 |
| OFO | Airway Suction Kit | 868.6810 | 1 | 0 |
| OFR | Tracheobronchial Suction Catheter Kit | 868.6810 | 1 | 0 |
| OFS | Tracheal Suction Set | 868.6810 | 1 | 0 |
| OYI | Non-Bronchoscopic Bronchoalveolar Lavage Catheter | 868.6810 | 1 | 1 |
| CCX | Support, Patient Position | 868.6820 | 1 | 8 |
| CAM | Yoke Assembly, Medical Gas | 868.6885 | 1 | 8 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | Trudell Medical Intl. | Oct 24, 2013 |
| K113338 | MEDICAL AIR COMPRESSOR | Oricare, Inc. | Aug 10, 2012 |
| K112562 | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER | Kimberly-Clark | Dec 15, 2011 |
| K091871 | DK50 DS | Ekom S.R.O. | Oct 23, 2009 |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | Emg Technology Co., Ltd. | Nov 19, 2008 |
| K060781 | MEDICAL COMPRESSOR, MODELS DK50 D AND DM | Ekom S.R.O. | Oct 3, 2006 |
| K051691 | MINIMATE COMPRESSOR | Precision Medical, Inc. | Dec 9, 2005 |
| K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | Hamilton Medical AG | Mar 14, 2005 |
| K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | Newport Medical Instruments | Dec 15, 2004 |
| K041974 | MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER | Med2000 S.R.L. | Aug 24, 2004 |
| K040220 | MEDICAL AIR COMPRESSOR | eVent Medical, Ltd. | Jun 9, 2004 |
| K031686 | AEROMIST LT, MODEL HCS15004 | Medline Industries, Inc. | Jan 21, 2004 |
| K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | Mallinckrodt Dar S.R.L. | Nov 25, 2003 |
| K031413 | VIGORMIST COMPRESSOR NEBULIZER | Vega Technologies, Inc. | Oct 7, 2003 |
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Siemens Elema AB | Sep 5, 2003 |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | Nidek Medical Products, Inc. | May 3, 2002 |
| K013027 | MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 | Respironics Healthscan, Inc. | Dec 6, 2001 |
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | Pari Holding Co. | Mar 13, 2001 |
| K002468 | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 | San UP S.A. | Mar 2, 2001 |
| K992902 | AMBU HAND POWER SUCTION PUMP | Ambu, Inc. | Oct 25, 1999 |
| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | Drager, Inc. | Oct 29, 1998 |
| K982945 | DUAL PURPOSE CLOSED CATHETER | Spirit Medical Systems, Inc. | Sep 22, 1998 |
| K981910 | SUCTION CATHETER | Ni-Med, Inc. | Aug 24, 1998 |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Mallinckrodt Medical | Dec 29, 1997 |
| K973199 | AMSINO SUCTION CATHETER | Amsino Intl., Inc. | Sep 10, 1997 |
| K963349 | DEVILBISS 8650D | Devilbiss Health Care, Inc. | Jun 13, 1997 |
| K961707 | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM | Sorenson Critical Care | Mar 11, 1997 |
| K964369 | TRACH CARE SET WITH MICROBAN | Ballard Medical Products | Feb 11, 1997 |
| K960488 | NEO 2 LINE SUCTION SYSTEM | Alcove Medical, Inc. | Apr 26, 1996 |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | Mar 28, 1996 |
| K955645 | CATH-GUIDE | Hudson Respiratory Care, Inc. | Mar 12, 1996 |
| K954804 | LUNG DIFFUSION MIXTURES | Mittler Supply, Inc. | Jan 25, 1996 |
| K954803 | BLOOD GAS MIXTURES | Mittler Supply, Inc. | Jan 25, 1996 |
| K954542 | LUNG DIFFUSION MIXTURE | Liquid Technology Corp. | Dec 22, 1995 |
| K951926 | ALRECO 40400 | Allan Rehnstrom AB | Dec 8, 1995 |
| K945478 | AM-50 AEROSOL/MEDICATION AIR COMPRESSOR | Preferred Medical Supply, Inc. | Sep 28, 1995 |
| K952616 | MICROTIME | Westmed Intl. | Sep 27, 1995 |
| K952838 | MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES | Standard Welders Supply Co. | Sep 19, 1995 |
| K953934 | MED-TECH LUNG DIFFUSION MIXTURE | Medical Technical Gases Inc.. | Sep 18, 1995 |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | Aug 15, 1995 |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | Aug 15, 1995 |
| K953226 | PULM O2 SUCTION CATHETER TRAYS | Premium Plastics, Inc. | Aug 8, 1995 |
| K953208 | MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES | Standard Welders Supply Co. | Jul 20, 1995 |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Trinity Laboratories, Inc. | Jul 3, 1995 |
| K945994 | DUAL PURPOSE CATHETER | Universal Medical Products, Inc. | Jun 21, 1995 |
| K946039 | MODEL #5000 PULMO PLUS | International Medical Systems | Jun 16, 1995 |
| K951745 | CONNECTING TUBE | Vital Signs, Inc. | May 30, 1995 |
| K940630 | 503 MAXI COMPRESSOR | Medical Industries America, Inc. | Feb 21, 1995 |
| K944998 | CALIBRATION GAS | Sunox, Inc. | Feb 3, 1995 |
| K944812 | CLINICAL BLOOD GAS MIXTURE | Laboratory & Specialty Gases, Inc. | Feb 1, 1995 |
| K945950 | TRIGUARD(TM) SUCTION SYSTEM | Vital Signs, Inc. | Dec 27, 1994 |
| K930509 | PM PUMP COMPRESSOR | Precision Medical, Inc. | Oct 28, 1994 |
| K943837 | CHIN UP | Edward Carden | Oct 14, 1994 |
| K944251 | KENDALL MODU-VAC CLOSED SUCTION SYSTEM | Kendall Healthcare Products Co. Div.Of Tyco Health | Sep 21, 1994 |
| K942866 | CLINICAL BLOOD GAS MIXTURE | Nordan Smith Welding Supplies | Sep 1, 1994 |
| K925010 | NEBULIZER PUMP, POWERED, MODEL 1110 | Thomas Industries | May 27, 1994 |
| K935600 | TRACHEAL SUCTION CATHETER | Puritas Health Care, Inc. | May 10, 1994 |
| K935583 | SUCTION SET, TRACHAEL | Puritas Health Care, Inc. | Apr 11, 1994 |
| K935283 | YOKE ASSEMBLY MEDICAL GAS | American Gage & Medical, Inc. | Mar 11, 1994 |
| K932874 | BLOOD GAS MIXTURE | Tri-Gas, Inc. | Jan 27, 1994 |
| K935553 | MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP | Puritas Health Care, Inc. | Jan 14, 1994 |
| K925011 | NEBULIZER PUMP, POWERED MODEL 1180 | Thomas Industries | Jan 12, 1994 |
| K935311 | CLINICAL BLOOD GAS | Acetylene Gas Co. | Dec 22, 1993 |
| K934723 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | Nov 30, 1993 |
| K932305 | VILA-COOKE(TM) ANESTHESIA PILLOW | Sharn, Inc. | Oct 5, 1993 |
| K934235 | SNIFF POSITION PILLOW | American Medical Development, Inc. | Oct 1, 1993 |
| K931015 | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER | Devilbiss Health Care, Inc. | Sep 30, 1993 |
| K932520 | CALIBRATION GAS | Cryodyne Technologies, Inc. | Aug 19, 1993 |
| K925556 | ARGYLE ASPIR-FLEX SUCTION CATHETER | Sherwood Medical Co. | Jul 30, 1993 |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | Boston Pacific Medical, Inc. | Jul 7, 1993 |
| K922843 | DYNAREX SUCTION CATHETERS & KITS | Dynarex Corp. | Jan 11, 1993 |
| K924487 | RED DOT 2515 CARDIAC SENSOR SYSTEM | 3M Health Care, Ltd. | Dec 23, 1992 |
| K924796 | LUNG DIFFUSION GAS MIXTURE | Gulf States Airgas | Dec 17, 1992 |
| K924795 | BLOOD GAS MIXTURE | Gulf States Airgas | Dec 17, 1992 |
| K913097 | SAM ST | Ferguson Medical | Dec 11, 1992 |
| K922148 | ARGYLE AERO-JET SUCTION CATHETER | Sherwood Medical Co. | Dec 7, 1992 |
| K922623 | NEBULIZER SYSTEM | Healthdyne, Inc. | Dec 1, 1992 |
| K924373 | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP | Instrumed, Inc. | Nov 25, 1992 |
| K923098 | STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE | Trinity Laboratories, Inc. | Sep 21, 1992 |
| K920954 | AIR STAR | Infrasonics Corp. | Aug 3, 1992 |
| K921710 | MOVIT DEVICE | John J. Navar, M.D. | Jun 29, 1992 |
| K903480 | HANN-VAC TM, DISPOSABLE,SUCTION CATHETER | Un-I-Med, Inc. | Oct 1, 1991 |
| K911264 | CALIBRATION KIT | S & W Medico Teknik | Aug 2, 1991 |
| K912596 | MECONIUM ASPIRATION | Pacific Device, Inc. | Jul 30, 1991 |
| K912346 | MEDIKEEPER | Medikeeper, Inc. | Jul 30, 1991 |
| K911471 | LUNG DIFFUSION GAS MIXTURES | Norco, Inc. | Jun 18, 1991 |
| K910239 | NEBU-SOL METERED DOSE DISPENSER (TM) | Dey Laboratories, Inc. | May 22, 1991 |
| K910909 | MUCAID | Vygon Corp. | May 20, 1991 |
| K910908 | MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING | Vygon Corp. | May 20, 1991 |
| K902520 | AIR PLUS NEBULIZER | Diamond Medical Equipment, Inc. | Mar 4, 1991 |
| K904045 | #504 MINI COMPRESSOR | Medical Industries America, Inc. | Feb 12, 1991 |
| K902184 | MAXI ASPIRATOR | Medical Industries America, Inc. | Feb 12, 1991 |
| K903552 | ORAL-CATH SUCTION CATHETER | Concord Protex | Jan 2, 1991 |
| K902754 | ANESTHETIC GAS CALIBRATION MIXTURE | Liquid Air Corp. | Dec 19, 1990 |
| K903740 | TRACH-EZE | Sorex Medical | Dec 6, 1990 |
| K902093 | RESU-GARD CATHETER SUCTION | Amg Medical Equipments, Inc. | Oct 23, 1990 |
| K903669 | GENESIS INSUFFLATING CATHETER | General Medical Co. | Sep 12, 1990 |
| K902687 | STERI-CATH-DL | Concord/Portex | Aug 29, 1990 |
| K902814 | SUCTION CATHETER, STERILE | Orion Life Systems, Inc. | Aug 17, 1990 |
| K902297 | BUSSE BAC/SHIELD | Busse Hospital Disposables, Inc. | Aug 17, 1990 |
