Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Summit Medical Products, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and amb | Summit Medical Products, Inc. | 2017-08-29 | 391 | 5 |
| K113043 | DIRECT ANTIBIOTIC INFUSION KIT | Summit Medical Products, Inc. | 2011-12-20 | 68 | 0 |
| K110814 | AMBIT TUNNELER | Summit Medical Products, Inc. | 2011-04-08 | 15 | 0 |
| K102460 | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH | Summit Medical Products, Inc. | 2011-01-13 | 139 | 0 |
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