Propper Mfg. Co., Inc.
Medical device manufacturer in Long Island, NY.
25510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K111453 | Steam Dot Blu Process IndicatorJOJ · Abbreviated | 04/05/2012SE |
| K102894 | Classix Chemical Sterilization IndicatorJOJ · Abbreviated | 05/25/2011SE |
| K082620 | Once-A-Day Vertos Test PackJOJ · Abbreviated | 07/08/2009SE |
| K031152 | Propper Vapor Line PCD (Steam Sterilization Process Challenge Test)JOJ · Traditional | 08/17/2004SE |
| K991618 | Bi-O.K. Self-Contained Biological IndicatorFRC · Traditional | 01/24/2001SE |
| K991276 | Pass/Fail Challenge PackJOJ · Traditional | 07/12/1999SE |
| K973585 | Propper Eo Line Ethylene Oxide Sterilization IntegratorJOJ · Traditional | 11/06/1998SE |
| K972747 | Bi-O.K. Eo Gas Biological Test-Pak (269305,269310,269320)FRC · Traditional | 01/09/1998SE |
| K961156 | Once-A-Day Bowie and Dick Test Pack.JOJ · Traditional | 04/01/1997SE |
| K921798 | Propper Super Seracult(R)KHE · Traditional | 10/05/1992SE |
| K915804 | Propper Laryngoscope Blades W Fiber Optic Illum.CCW · Traditional | 03/20/1992SE |
| K903024 | Bi-O.K. Steam Test-PakFRC · Traditional | 09/12/1990SE |
| K895910 | SteamlineJOJ · Traditional | 08/22/1990SE |
| K891784 | Bi-O.K.(Tm)-Biological/Chemical IndicatorFRC · Traditional | 02/09/1990SE |
| K871672 | Sterilization Indicator for Flash SterilizationLRT · Traditional | 06/01/1987SE |
| K851804 | Bio-Challenge Test PakJOJ · Traditional | 07/16/1985SE |
| K834353 | Ok Flash Sterilization IndicatorJOJ · Traditional | 03/19/1984SE |
| K834297 | Propper SeracultKHE · Traditional | 01/27/1984SE |
| K821648 | Gas Chex Plastic BagJOJ · Traditional | 06/22/1982SE |
| K813204 | Seracult Occult Bloof TestKHE · Traditional | 01/28/1982SE |
| K810506 | Propper Sigmoidoscope Suction InstrumentOCX · Traditional | 04/07/1981SE |
| K802428 | Propper Sharpguard & Traypad Steril. AidFRG · Traditional | 10/23/1980SE |
| K771920 | Fiber Optics ProctoscopeGCP · Traditional | 10/20/1977SE |
| K771919 | Fiber Optics SigmoidoscopeGCP · Traditional | 10/20/1977SE |
| K771918 | Fibeo Optics Illum. SystemGCP · Traditional | 10/20/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2330-2008 | Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No.…The firm discovered a production specification discrepancy that may cause the indicators to show an… | 02/07/2008Terminated |