# Summit Medical, Inc.

- Location (FDA's records): St. Paul, MN
- FDA decisions: 14 (2002–2018): 14 510(k) clearances
- Names in FDA's records: Summit Medical, Inc. (9); Summit Medical , Ltd. (5)
- Product codes: KCT (8), CAC (2), CAK (1), DYX (1), MBI (1), BSP (1)
- 510(k) review time since 2016: median 231 days, against 192 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 13 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pajunk GmbH: 2 (https://510kreport.com/company/pajunk)
- Ermis Medizintechnik: 1 (https://510kreport.com/company/ermis-medizintechnik)
- Pall Biomedical Products Co.: 1 (https://510kreport.com/company/pall-biomedical-products)
- Duxbury Scientific, Inc.: 1 (https://510kreport.com/company/duxbury-scientific)
- Zygomatics, Ltd.: 1 (https://510kreport.com/company/zygomatics)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)

## Firms that cite its devices most
- Inari Medical, Inc.: 1 (https://510kreport.com/company/inari-medical)
- Summitt Medical, LLC: 1 (https://510kreport.com/company/summitt-medical)
- Sterizign Precision Technologies, LLC: 1 (https://510kreport.com/company/sterizign-precision-technologies)

## Its most-cited devices
- K133015: Instru-Safe Instrument Protection System (2014), cited by 5
- K024097: Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14 (2003), cited by 1
- K022477: Summit Medical LTD Transfusion Filter, Model LF400 & Summit Medical LTD Transfusion Filter with Administration Set (2002), cited by 1
- K022489: Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models ABT4510, ABT4512 & ABT4514 (2002), cited by 1
- K150540: Instru-Safe Instrument Protection System (2015), cited by 1

## Recent decisions
- K180528: InstruSafe (R) Sterilization Container (Nov 16, 2018)
- K173110: Graftsite (May 18, 2018)
- K170388: ANCHORMAN Tibial Ligament Fixation Device (Jul 25, 2017)
- K162046: MINNE TIES MMF Suture System (Apr 11, 2017)
- K151166: Instru-Safe Instrument Protection System (Aug 18, 2015)
- K150540: Instru-Safe Instrument Protection System (Jun 22, 2015)
- K142768: Instru-Safe Instrument Protection System (May 29, 2015)
- K142630: Instru-Safe Instrument Protection System (Dec 23, 2014)

Source page: https://510kreport.com/company/summit-medical