Martin Medical: FDA clearances and approvals
Martin Medical has 14 FDA 510(k) clearances (first 1986, latest 1987), across 5 product codes in 4 review panels. Median 510(k) review time: 17 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LGF | Component, Cast | 6 | 6 |
| LGH | Instrument, Cast Removal, Ac-Powered | 4 | 4 |
| HIB | Speculum, Vaginal, Nonmetal | 2 | 2 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
Most recent Martin Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873723 | PLASTER VACUUM, 230V MODEL NO. 4183-161 | LGH | 1987-12-10 | 86 |
| K873721 | PLASTER VACUUM, 115V MODEL NO. 4183-160 | LGH | 1987-12-07 | 83 |
| K873722 | PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 | LGF | 1987-10-02 | 17 |
| K873720 | CAST CUTTER, 230V MODEL NO. 4183-107 | LGH | 1987-10-02 | 17 |
| K873719 | CAST CUTTER, 115V MODEL NO. 4183-106 | LGH | 1987-10-02 | 17 |
| K873718 | CHILD WALKING HEEL PRODUCT NO. 4183-132 | LGF | 1987-10-02 | 17 |
| K873717 | CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 | LGF | 1987-10-02 | 17 |
| K873716 | ADULT WALKING HEEL PRODUCT NO. 4183-130 | LDF | 1987-10-02 | 17 |
| K863273 | MARTIN MEDICAL PRO-SCOPE ANOSCOPE | KOA | 1986-11-04 | 71 |
| K863275 | MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM | HIB | 1986-09-02 | 8 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Martin Medical.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Martin Medical have?
Martin Medical has 14 FDA 510(k) clearances (first 1986, latest 1987), across 5 product codes in 4 review panels.
How long does FDA take to clear Martin Medical's 510(k)s?
The median time from FDA receipt to decision across Martin Medical's cleared 510(k)s is 17 days.
What devices does Martin Medical make?
Its most frequent FDA product codes are LGF (Component, Cast, 6); LGH (Instrument, Cast Removal, Ac-Powered, 4); HIB (Speculum, Vaginal, Nonmetal, 2).
Has Martin Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Martin Medical. Related entities may recall under other names.
Next steps
- See all 14 Martin Medical clearances with predicates and recalls
- Run predicate analysis for product code LGF, Martin Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.