Propper Manufacturing Co., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Propper Manufacturing Co., Inc.” (first 2014, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 114 days, against 139 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 90 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 86 |
| 2022 | 2 | 148 |
| 2023 | 0 | — |
| 2024 | 1 | 71 |
| 2025 | 1 | 270 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Propper Manufacturing Co., Inc. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 5 | 5 |
| FRG | Wrap, Sterilization | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
Review panels
- General Hospital (6)
- Ophthalmic (1)
Most recent Propper Manufacturing Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250306 | Chex-All Sterilization Pouches and Tubes | FRG | 2025-10-31 | 270 |
| K240910 | EO Chex Indicator Tape | JOJ | 2024-06-12 | 71 |
| K222137 | OK Plus Indicator | JOJ | 2022-12-05 | 139 |
| K212592 | Gas-Chex Indicator | JOJ | 2022-01-20 | 157 |
| K210866 | Steri-Dot Process Indicator | JOJ | 2021-06-21 | 90 |
| K210553 | Steam-Dot Process Indicator | JOJ | 2021-05-19 | 83 |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | HLI | 2014-09-17 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Propper Manufacturing Co., 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Propper Mfg. Co., Inc. (25 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Propper Manufacturing Co., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Propper Manufacturing Co., Inc.” (first 2014, latest 2025), across 3 product codes in 2 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 Propper Manufacturing Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Propper Manufacturing Co., Inc. is 90 days. Since 2017: 114 days, versus 139 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Propper Manufacturing Co., Inc.?
The most frequent FDA product codes under this applicant name are JOJ (Indicator, Physical/Chemical Sterilization Process, 5); FRG (Wrap, Sterilization, 1); HLI (Ophthalmoscope, Ac-Powered, 1).
Next steps
- See all 7 Propper Manufacturing Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Propper Manufacturing Co., 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.