Post Medical, Inc.: FDA clearances and approvals
Post Medical, Inc. has 6 FDA 510(k) clearances (first 1983, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time: 70 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Post Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990371 | DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 | FMI | 1999-04-21 | 72 |
| K972536 | SYRINGE NEEDLE REMOVER (S.N.R.) | FMI | 1997-08-15 | 68 |
| K925086 | AUTOMATIC NEEDLE DISCONECT (A.N.D.) | FMI | 1994-05-09 | 579 |
| K925816 | SHARPS CONTAINMENT SYSTEM | FMI | 1994-04-29 | 528 |
| K830946 | MALE EXTERNAL CATHETER | KNX | 1983-04-28 | 35 |
| K830947 | SYRINGE/NEEDLE DISPOS-BOX-CUTTER/CRIMPER | — | 1983-04-12 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Post Medical, 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 Post Medical, Inc. have?
Post Medical, Inc. has 6 FDA 510(k) clearances (first 1983, latest 1999), across 3 product codes in 2 review panels.
How long does FDA take to clear Post Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Post Medical, Inc.'s cleared 510(k)s is 70 days.
What devices does Post Medical, Inc. make?
Its most frequent FDA product codes are FMI (Needle, Hypodermic, Single Lumen, 4); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 1).
Has Post Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Post Medical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Post Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Post Medical, 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.