Bi-O.K. Self-Contained Biological Indicator
FDA 510(k) K991618 · Propper Mfg. Co., Inc.
510(k) numberK991618
Submission
- Device name
- Bi-O.K. Self-Contained Biological Indicator
- Applicant
- Propper Mfg. Co., Inc.
Long Island, NY, US - Received
- May 11, 1999
- Decision date
- January 24, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code FRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 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 |
| 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 |
Questions and answers
When was Bi-O.K. Self-Contained Biological Indicator cleared by the FDA?
Bi-O.K. Self-Contained Biological Indicator (K991618) received a 510(k) decision of Substantially Equivalent on January 24, 2001, 624 days after the submission was received.
What is the product code of K991618?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.