Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Martell Medical Products, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
158 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945454 | LEUR TIP CAP, VLT CAP(TM) | Martell Medical Products, Inc. | 1995-04-14 | 158 | 0 |
| K944941 | PISTON SYRINGE | Martell Medical Products, Inc. | 1994-12-05 | 59 | 1 |
| K841810 | MARK5 ARTERIAL BLOOD GAS KIT | Martell Medical Products, Inc. | 1984-07-06 | 66 | 0 |
| K822786 | MDM ARTERIAL BLOOD GAS KIT | Martell Medical Products, Inc. | 1982-10-21 | 36 | 0 |
| K822760 | ARTERIAL LINE KIT | Martell Medical Products, Inc. | 1982-09-28 | 14 | 0 |
| K821096 | A-LINER | Martell Medical Products, Inc. | 1982-05-14 | 24 | 0 |
| K812560 | MDM ARTERIAL BLOOD GAS SYRINGE | Martell Medical Products, Inc. | 1981-10-09 | 31 | 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