Company ยท US
Propper Mfg. Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2012. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 12 |
| FRC | Indicator, Biological Sterilization Process | 4 |
| GCP | Endoscope, Ac-Powered And Accessories | 3 |
| KHE | Reagent, Occult Blood | 3 |
| CCW | Laryngoscope, Rigid | 1 |
| FRG | Wrap, Sterilization | 1 |
| G-I | 1 | |
| LRT | Indicator, Sterilization | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 5, 2012 | K111453 | STEAM DOT BLU PROCESS INDICATOR Propper Mfg. Co., Inc. | JOJ |
| May 25, 2011 | K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR Propper Mfg. Co., Inc. | JOJ |
| Jul 8, 2009 | K082620 | ONCE-A-DAY VERTOS TEST PACK Propper Mfg. Co., Inc. | JOJ |
| Aug 17, 2004 | K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) Propper Mfg. Co., Inc. | JOJ |
| Jan 24, 2001 | K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR Propper Mfg. Co., Inc. | FRC |
| Jul 12, 1999 | K991276 | PASS/FAIL CHALLENGE PACK Propper Mfg. Co., Inc. | JOJ |
| Nov 6, 1998 | K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR Propper Mfg. Co., Inc. | JOJ |
| Jan 9, 1998 | K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) Propper Mfg. Co., Inc. | FRC |
| Apr 1, 1997 | K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. Propper Mfg. Co., Inc. | JOJ |
| Oct 5, 1992 | K921798 | PROPPER SUPER SERACULT(R) Propper Mfg. Co., Inc. | KHE |
| Mar 20, 1992 | K915804 | PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. Propper Mfg. Co., Inc. | CCW |
| Sep 12, 1990 | K903024 | BI-O.K. STEAM TEST-PAK Propper Mfg. Co., Inc. | FRC |
| Aug 22, 1990 | K895910 | STEAMLINE Propper Mfg. Co., Inc. | JOJ |
| Feb 9, 1990 | K891784 | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR Propper Mfg. Co., Inc. | FRC |
| Jun 1, 1987 | K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION Propper Mfg. Co., Inc. | LRT |
| Jul 16, 1985 | K851804 | BIO-CHALLENGE TEST PAK Propper Mfg. Co., Inc. | JOJ |
| Mar 19, 1984 | K834353 | OK FLASH STERILIZATION INDICATOR Propper Mfg. Co., Inc. | JOJ |
| Jan 27, 1984 | K834297 | PROPPER SERACULT Propper Mfg. Co., Inc. | KHE |
| Jun 22, 1982 | K821648 | GAS CHEX PLASTIC BAG Propper Mfg. Co., Inc. | JOJ |
| Jan 28, 1982 | K813204 | SERACULT OCCULT BLOOF TEST Propper Mfg. Co., Inc. | KHE |
| Apr 7, 1981 | K810506 | PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT Propper Mfg. Co., Inc. | OCX |
| Oct 23, 1980 | K802428 | PROPPER SHARPGUARD & TRAYPAD STERIL. AID Propper Mfg. Co., Inc. | FRG |
| Oct 20, 1977 | K771920 | FIBER OPTICS PROCTOSCOPE Propper Mfg. Co., Inc. | GCP |
| Oct 20, 1977 | K771919 | FIBER OPTICS SIGMOIDOSCOPE Propper Mfg. Co., Inc. | GCP |
| Oct 20, 1977 | K771918 | FIBEO OPTICS ILLUM. SYSTEM Propper Mfg. Co., Inc. | GCP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Propper Mfg Co Inc Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101 Terminated |
JOJ | None listed |
| Oct 24, 2003 | Propper Mfg Co Inc 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.
Cali Terminated |
G-I | None listed |