Data / Medical devices / United States / Propper MFG. Co., Inc.
Propper MFG. Co., Inc.: FDA-registered device maker in Long Island City, NY, United States, 20 510(k) clearances
Propper MFG. Co., Inc. is registered with the FDA (registration 2410251) in Long Island City, NY, United States. It lists 9 device types. The FDA files 20 510(k) clearances under its listings, the newest dated June 12, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2410251
- Address
- 36-04 Skillman Ave., Long Island City, NY, United States, 11101
- Owner or operator
- Propper Manufacturing Co., Inc. (2410251)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 27, 1978
- Registered through
- 2026
- Brand names listed
- Chex All® sterilization pouches and tubes, DUO-SPORE, EO Chex Indicator Tape, Gas-Chex® Indicator Strips, HEMACYTOMETER COUNTING CHAMBER, HEMACYTOMETER COUNTING CHAMBER LUMICYTE, Magnalume disposable laryngoscope blades, O.K. steam indicator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Hemocytometer | GHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Indicator, Sterilization | LRT | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2024 | K240910 | EO Chex Indicator Tape | JOJ | Substantially Equivalent | Propper Manufacturing Co., Inc. | accessdata.fda.gov |
| January 20, 2022 | K212592 | Gas-Chex Indicator | JOJ | Substantially Equivalent | Propper Manufacturing Co., Inc. | accessdata.fda.gov |
| June 21, 2021 | K210866 | Steri-Dot Process Indicator | JOJ | Substantially Equivalent | Propper Manufacturing Co., Inc. | accessdata.fda.gov |
| May 19, 2021 | K210553 | Steam-Dot Process Indicator | JOJ | Substantially Equivalent | Propper Manufacturing Co., Inc. | accessdata.fda.gov |
| June 28, 2016 | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | JOJ | Substantially Equivalent | Canadian Technical Tape, Ltd. | accessdata.fda.gov |
| April 5, 2012 | K111453 | STEAM DOT BLU PROCESS INDICATOR | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| May 25, 2011 | K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| July 8, 2009 | K082620 | ONCE-A-DAY VERTOS TEST PACK | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| August 17, 2004 | K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| July 12, 1999 | K991276 | PASS/FAIL CHALLENGE PACK | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| April 1, 1997 | K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| May 23, 1996 | K960777 | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR | FRC | Substantially Equivalent | Mdt Corp., Inc. | accessdata.fda.gov |
| October 5, 1992 | K921798 | PROPPER SUPER SERACULT(R) | KHE | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| September 12, 1990 | K903024 | BI-O.K. STEAM TEST-PAK | FRC | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| August 22, 1990 | K895910 | STEAMLINE | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| February 9, 1990 | K891784 | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR | FRC | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| March 19, 1984 | K834353 | OK FLASH STERILIZATION INDICATOR | JOJ | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| January 27, 1984 | K834297 | PROPPER SERACULT | KHE | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| January 28, 1982 | K813204 | SERACULT OCCULT BLOOF TEST | KHE | Substantially Equivalent | Propper Mfg. Co., Inc. | accessdata.fda.gov |
| February 6, 1980 | K792648 | UNILAB CULTURING SET | FRC | Substantially Equivalent | Sybron Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 7, 2008 | 48969 | Not yet classified | Terminated | Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101 | The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result. | accessdata.fda.gov |
| August 9, 2002 | 26844 | Not yet classified | Terminated | propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end fo | Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Indicator, Biological Sterilization Process
- All makers of Reagent, Occult Blood
- All makers of Laryngoscope, Rigid
- All makers of Hemocytometer
Updated June 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.