← Product Code [BTA](/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA) · K964997 # S-SCORT (2500) (K964997) _Sscor · BTA · Mar 5, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA/K964997 ## Device Facts - **Applicant:** Sscor - **Product Code:** [BTA](/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA.md) - **Decision Date:** Mar 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4780 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. 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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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA/K964997](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA/K964997) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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