Propper Mfg. Co., Inc.
FDA Regulatory Profile
Propper Mfg. Co., Inc. has 0 FDA recalls, 6 inspections, 25 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jun 13, 2024 · VAI
- Latest 510(k)
- Apr 5, 2012
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 25 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jun 13, 2024 | Long Island City, NY | Devices | Voluntary Action Indicated (VAI) | 2410251 |
| Sep 14, 2021 | Long Island City, NY | Devices | No Action Indicated (NAI) | 2410251 |
| Dec 21, 2017 | Long Island City, NY | Devices | Voluntary Action Indicated (VAI) | 2410251 |
| Mar 18, 2015 | Long Island City, NY | Devices | Voluntary Action Indicated (VAI) | 2410251 |
| Oct 3, 2012 | Long Island City, NY | Devices | Voluntary Action Indicated (VAI) | 2410251 |
| Oct 27, 2010 | Long Island City, NY | Devices | Voluntary Action Indicated (VAI) | 2410251 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 2410251 | Long Island City, NY | 6 | Jun 13, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K111453 | STEAM DOT BLU PROCESS INDICATOR | Apr 5, 2012 |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | May 25, 2011 |
| K082620 | ONCE-A-DAY VERTOS TEST PACK | Jul 8, 2009 |
| K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) | Aug 17, 2004 |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | Jan 24, 2001 |
| K991276 | PASS/FAIL CHALLENGE PACK | Jul 12, 1999 |
| K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR | Nov 6, 1998 |
| K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) | Jan 9, 1998 |
| K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | Apr 1, 1997 |
| K921798 | PROPPER SUPER SERACULT(R) | Oct 5, 1992 |
| K915804 | PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. | Mar 20, 1992 |
| K903024 | BI-O.K. STEAM TEST-PAK | Sep 12, 1990 |
| K895910 | STEAMLINE | Aug 22, 1990 |
| K891784 | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR | Feb 9, 1990 |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | Jun 1, 1987 |
| K851804 | BIO-CHALLENGE TEST PAK | Jul 16, 1985 |
| K834353 | OK FLASH STERILIZATION INDICATOR | Mar 19, 1984 |
| K834297 | PROPPER SERACULT | Jan 27, 1984 |
| K821648 | GAS CHEX PLASTIC BAG | Jun 22, 1982 |
| K813204 | SERACULT OCCULT BLOOF TEST | Jan 28, 1982 |