Propper Mfg. Co., Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Propper Mfg. Co., Inc.” (first 1977, latest 2012), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 89 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 | 1 | 316 |
| 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 11 | 11 |
| FRC | Indicator, Biological Sterilization Process | 4 | 4 |
| GCP | Endoscope, Ac-Powered And Accessories | 3 | 3 |
| KHE | Reagent, Occult Blood | 3 | 3 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| LRT | Indicator, Sterilization | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Review panels
- General Hospital (17)
- Gastroenterology and Urology (4)
- Hematology (3)
- Anesthesiology (1)
Most recent Propper Mfg. Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111453 | STEAM DOT BLU PROCESS INDICATOR | JOJ | 2012-04-05 | 316 |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | JOJ | 2011-05-25 | 237 |
| K082620 | ONCE-A-DAY VERTOS TEST PACK | JOJ | 2009-07-08 | 302 |
| K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) | JOJ | 2004-08-17 | 494 |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | 2001-01-24 | 624 |
| K991276 | PASS/FAIL CHALLENGE PACK | JOJ | 1999-07-12 | 89 |
| K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR | JOJ | 1998-11-06 | 410 |
| K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) | FRC | 1998-01-09 | 170 |
| K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | JOJ | 1997-04-01 | 375 |
| K921798 | PROPPER SUPER SERACULT(R) | KHE | 1992-10-05 | 174 |
15 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2008-02-07.
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 Manufacturing Co., Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Propper Mfg. Co., Inc.?
FDA lists 25 510(k) clearances under the applicant name “Propper Mfg. Co., Inc.” (first 1977, latest 2012), across 8 product codes in 4 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 Mfg. Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Propper Mfg. Co., Inc. is 89 days.
Which FDA product codes appear under Propper Mfg. Co., Inc.?
The most frequent FDA product codes under this applicant name are JOJ (Indicator, Physical/Chemical Sterilization Process, 11); FRC (Indicator, Biological Sterilization Process, 4); GCP (Endoscope, Ac-Powered And Accessories, 3).
Next steps
- See all 25 Propper Mfg. Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Propper Mfg. 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.