Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Martech Medical Products, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
329 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960519 | MARTECH ENDOSCOPIC INJECTION NEEDLE | Martech Medical Products, Inc. | 1996-05-01 | 86 | 0 |
| K931924 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Martech Medical Products, Inc. | 1993-08-03 | 109 | 0 |
| K922438 | PRO2 OXYGEN ANALYZER | Martech Medical Products, Inc. | 1993-03-05 | 287 | 0 |
| K926007 | ACCESSORY TO PISTON SYRINGE | Martech Medical Products, Inc. | 1993-02-23 | 88 | 0 |
| K914778 | NEOLINE(TM) | Martech Medical Products, Inc. | 1992-09-16 | 329 | 0 |
| K910970 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Martech Medical Products, Inc. | 1991-10-15 | 222 | 0 |
| K890473 | NEEDLE GUARD(TM) | Martech Medical Products, Inc. | 1989-04-03 | 62 | 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