Simpex, Inc.: FDA clearances and approvals
Simpex, Inc. has 5 FDA 510(k) clearances (first 1991, latest 1992), across 4 product codes in 3 review panels. Median 510(k) review time: 89 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
Most recent Simpex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920174 | EASY TOUCH LATEX EAM GLOVES | LYY | 1992-04-22 | 99 |
| K913793 | SIMPEX INC. ORAL AND RECTAL THERMOMETERS | FLK | 1991-12-30 | 129 |
| K913794 | SIMPEX INC. SURGICAL DRESSING | GDY | 1991-11-20 | 89 |
| K911505 | FIXATION WIRE | HTY | 1991-04-12 | 8 |
| K911452 | FIXATION PIN | HTY | 1991-04-12 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Simpex, Inc..
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 Simpex, Inc. have?
Simpex, Inc. has 5 FDA 510(k) clearances (first 1991, latest 1992), across 4 product codes in 3 review panels.
How long does FDA take to clear Simpex, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Simpex, Inc.'s cleared 510(k)s is 89 days.
What devices does Simpex, Inc. make?
Its most frequent FDA product codes are HTY (Pin, Fixation, Smooth, 2); FLK (Thermometer, Clinical Mercury, 1); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 1).
Has Simpex, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Simpex, Inc. Related entities may recall under other names.
Next steps
- See all 5 Simpex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HTY, Simpex, Inc.'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.