Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Summit Medical , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
231 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173110 | GRAFTSITE | Summit Medical , Ltd. | 2018-05-18 | 231 | 0 |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | Summit Medical , Ltd. | 2017-07-25 | 167 | 0 |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION S | Summit Medical , Ltd. | 2003-02-14 | 64 | 0 |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT | Summit Medical , Ltd. | 2002-10-25 | 88 | 0 |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION S | Summit Medical , Ltd. | 2002-10-09 | 72 | 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