Martech Medical Products, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Martech Medical Products, Inc.” (first 1989, latest 2026), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 123 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 264 |
| 2013 | 1 | 123 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 273 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Martech Medical Products, Inc. took a median 273 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 3 | 3 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| PTI | Non-Coring (Huber) Needle | 1 | 1 |
Review panels
- Cardiovascular (3)
- General Hospital (3)
- Anesthesiology (2)
- Clinical Chemistry (2)
- Gastroenterology and Urology (1)
Most recent Martech Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254095 | 25G Huber Needle | PTI | 2026-09-18 | 273 |
| K130855 | PTFE SUPER SHEATH INTRODUCER | DYB | 2013-07-29 | 123 |
| K120617 | PTFE SUPER SHEATH INTRODUCER | DYB | 2012-11-19 | 264 |
| K101399 | COAXIAL INTRODUCER SET | DYB | 2010-06-17 | 30 |
| K960519 | MARTECH ENDOSCOPIC INJECTION NEEDLE | FBK | 1996-05-01 | 86 |
| K931924 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | JKA | 1993-08-03 | 109 |
| K922438 | PRO2 OXYGEN ANALYZER | CCL | 1993-03-05 | 287 |
| K926007 | ACCESSORY TO PISTON SYRINGE | FMF | 1993-02-23 | 88 |
| K914778 | NEOLINE(TM) | CBT | 1992-09-16 | 329 |
| K910970 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | JKA | 1991-10-15 | 222 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Martech Medical Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Martech Medical Products, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Martech Medical Products, Inc.” (first 1989, latest 2026), across 8 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Martech Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Martech Medical Products, Inc. is 123 days.
Which FDA product codes appear under Martech Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 3); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 2); CBT (Arterial Blood Sampling Kit, 1).
Next steps
- See all 11 Martech Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Martech Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.