Pm America, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pm America, Inc.” (first 1980, latest 1983), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 18 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 | 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 3 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
Review panels
Most recent Pm America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830319 | AUTO PREP | JQW | 1983-03-29 | 57 |
| K820748 | POLI-MAK MODEL F-4 (FINAL | JJF | 1982-04-06 | 18 |
| K813102 | POLI-MAK II | JJE | 1981-11-24 | 21 |
| K812983 | DSD | JQW | 1981-11-10 | 15 |
| K801271 | MODEL 4900 OFF-LINE PREPARATION SYSTEM | JQW | 1980-06-09 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Pm America, 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 Pm America, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Pm America, Inc.” (first 1980, latest 1983), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pm America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pm America, Inc. is 18 days.
Which FDA product codes appear under Pm America, Inc.?
The most frequent FDA product codes under this applicant name are JQW (Station, Pipetting And Diluting, For Clinical Use, 3); JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 1); JJF (Analyzer, Chemistry, Micro, For Clinical Use, 1).
Next steps
- See all 5 Pm America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JQW, Pm America, 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.