Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sam Medical Products — 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) |
|---|---|---|---|---|---|
| K133121 | CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3I | Sam Medical Products | 2014-05-22 | 234 | 0 |
| K131561 | SAM JUNCTIONAL TOURNIQUET | Sam Medical Products | 2013-07-24 | 55 | 1 |
| K123694 | SAM JUNCTIONAL TOURNIQUET | Sam Medical Products | 2013-03-07 | 94 | 1 |
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 | 191 | 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