Propper Mfg Co Inc
Long Island City, NY, US
PROPPER MFG. CO., INC. appears in FDA device records in Long Island City, NY. FDA records list 25 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 25 510(k) clearances for Propper Mfg Co Inc between 1977 and 2012. The busiest year on record is 1977, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 2 |
| 1984 | 2 |
| 1985 | 1 |
| 1987 | 1 |
| 1990 | 3 |
| 1992 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2001 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111453 | STEAM DOT BLU PROCESS INDICATOR | JOJ | Substantially Equivalent | |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | JOJ | Substantially Equivalent | |
| K082620 | ONCE-A-DAY VERTOS TEST PACK | JOJ | Substantially Equivalent | |
| K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) | JOJ | Substantially Equivalent | |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | |
| K991276 | PASS/FAIL CHALLENGE PACK | JOJ | Substantially Equivalent | |
| K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR | JOJ | Substantially Equivalent | |
| K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) | FRC | Substantially Equivalent | |
| K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | JOJ | Substantially Equivalent | |
| K921798 | PROPPER SUPER SERACULT(R) | KHE | Substantially Equivalent | |
| K915804 | PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. | CCW | Substantially Equivalent | |
| K903024 | BI-O.K. STEAM TEST-PAK | FRC | Substantially Equivalent | |
| K895910 | STEAMLINE | JOJ | Substantially Equivalent | |
| K891784 | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR | FRC | Substantially Equivalent | |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | LRT | Substantially Equivalent | |
| K851804 | BIO-CHALLENGE TEST PAK | JOJ | Substantially Equivalent | |
| K834353 | OK FLASH STERILIZATION INDICATOR | JOJ | Substantially Equivalent | |
| K834297 | PROPPER SERACULT | KHE | Substantially Equivalent | |
| K821648 | GAS CHEX PLASTIC BAG | JOJ | Substantially Equivalent | |
| K813204 | SERACULT OCCULT BLOOF TEST | KHE | Substantially Equivalent | |
| K810506 | PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT | OCX | Substantially Equivalent | |
| K802428 | PROPPER SHARPGUARD & TRAYPAD STERIL. AID | FRG | Substantially Equivalent | |
| K771920 | FIBER OPTICS PROCTOSCOPE | GCP | Substantially Equivalent | |
| K771919 | FIBER OPTICS SIGMOIDOSCOPE | GCP | Substantially Equivalent | |
| K771918 | FIBEO OPTICS ILLUM. SYSTEM | GCP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2410251 | 2410251 | PROPPER MFG. CO., INC. | 36-04 SKILLMAN AVE., Long Island City, NY 11101 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GESBlade, Scalpel
- GCPEndoscope, Ac-Powered And Accessories
- OCXEndoscopic Irrigation/Suction System
- GHOHemocytometer
- FRCIndicator, Biological Sterilization Process
- JOJIndicator, Physical/Chemical Sterilization Process
- LRTIndicator, Sterilization
- CCWLaryngoscope, Rigid
- KHEReagent, Occult Blood
- GAXTourniquet, Nonpneumatic
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2330-2008 | 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. | Terminated | ||
| Z-0051-04 | 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 for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain