Who is the manufacturer of S-SCORT (2500)?

Sscor filed the 510(k) submission for S-SCORT (2500) (K964997).

What is the FDA product code for S-SCORT (2500)?

BTA. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for S-SCORT (2500)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like S-SCORT (2500)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

S-SCORT (2500)

Q: What are the predicate devices for S-SCORT (2500)?

SSCOR S-SCORT® Jr. Model 90024B.

K964997 · Sscor · BTA · Mar 5, 1997 · General, Plastic Surgery

Device Facts

Record ID	K964997
Device Name	S-SCORT (2500)
Applicant	Sscor
Product Code	BTA · General, Plastic Surgery
Decision Date	Mar 5, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. The unit comes equipped with a pump, regulator, battery, canister, suction tubing, suction tip with vent control, and carrying case. It can be used in hospital crash cart suction; patient transport; surgi-center back-up suction; emergency medical service; and home health care/nursing homes.

Device Story

Portable suction pump; provides constant suction for aspiration. Components: pump, regulator, battery, canister, suction tubing, suction tip with vent control, carrying case. Operated by professional personnel in clinical, transport, and home care environments. Device generates negative pressure to clear airways or surgical sites; assists healthcare providers in maintaining patient airway patency or removing fluids. Benefits: portable, battery-powered suction capability for emergency and routine clinical use.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate.

Technological Characteristics

Powered portable suction apparatus. Components: pump, regulator, battery, canister, suction tubing, suction tip with vent control. Operates via electrical input/output to generate negative pressure and airflow. Portable form factor with carrying case.

Indications for Use

Indicated for professional personnel requiring constant suctioning in hospital, transport, surgi-center, emergency medical service, and home health/nursing home settings.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

SSCOR S-SCORT® Jr. Model 90024B

Related Devices

K982304 — DEVILBISS SUCTION UNIT · Sunrise Medical Hhg, Inc. · Sep 25, 1998
K062456 — NOVASPINE POWERED SUCTION PUMP PRO-1 · Novaspine, LLC · Oct 16, 2006
K062610 — CARE-E-VAC 3 · Ohio Medical Corporation · Sep 28, 2006
K041154 — S-SCORT...JR QUICKDRAW, MODEL 2400 · Sscor · May 18, 2004
K251101 — AIRO Suction Unit (AIRO-01) · Cro, LLC · Apr 26, 2025

Submission Summary (Full Text)

{0} SSCOR, Inc. S-SCORT Model 2500 510(k) Notification K964997 # SUMMARY OF SAFETY AND EFFECTIVENESS # S-SCORT® MODEL 2500 PORTABLE SUCTION PUMP MAR - 5 1997 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. 1. **510(k) Submitter, Contact Person and Date Summary Prepared:** Sam Say SSCOR, Inc. 11064 Randall Street Sun Valley, CA 91352 (818) 504-4054 2. **Device Name:** Trade/Proprietary Name: S-SCORT® Model 2500 Portable Suction Pump Common/Usual Names: Powered Portable Aspiration Pump Powered Portable Suction Apparatus Classification Name: Powered Suction Pump 3. **Substantial Equivalence Information:** Predicate devices of the same type which the S-SCORT® Model 2500 Portable Suction Pump is substantially equivalent for purposes of Section 510(k) of the Food, Drug and Cosmetic Act: SSCOR S-SCORT® Jr. Model 90024B 4. **Device Description and Indications:** The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. The unit comes equipped with a pump, regulator, battery, canister, suction tubing, suction tip with vent control, and carrying case. It can be used in hospital crash cart suction; patient transport; surgi-center back-up suction; emergency medical service; and home health care/nursing homes. 5. **Comparison of Technological Characteristics with Predicate Devices:** The S-SCORT® Model 2500 is technologically similar in design and operation to the predicate devices with respect to pump, battery, regulator, electrical input & output, airflow, and negative pressure.