Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Summit Medical, Inc. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

169 daysmedian FDA review time
261 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K180528InstruSafe(R) Sterilization ContainerSummit Medical, Inc.2018-11-162610
K162046MINNE TIES MMF Suture SystemSummit Medical, Inc.2017-04-112600
K151166Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-08-181090
K150540Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-06-221110
K142768Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-05-292460
K142630Instru-Safe Instrument Protection SystemSummit Medical, Inc.2014-12-23970
K141513INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-12-151890
K140289INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-06-271420
K133015INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-03-131690

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda