FDA applicant
Summit Medical, Inc.
FDA records 14 decisions for Summit Medical, Inc. (St. Paul, MN) from 2002 to 2018: 14 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and CAC (Apparatus, Autotransfusion). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 192 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Summit Medical , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Summit Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Summit Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Summit”
FDA records each applicant name separately; these may or may not be the same firm.