Assert Eo Biological Test Pack
FDA 510(k) K854631 · Surgicot, Inc.
510(k) numberK854631
Submission
- Device name
- Assert Eo Biological Test Pack
- Applicant
- Surgicot, Inc.
Smithtown, NY, US - Received
- November 18, 1985
- Decision date
- May 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| 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 |
|---|---|---|
| K962605 | Pro-Guard Double-Duty Sterilization Wrap (Single Use)FRG · Traditional | 03/11/1997SE |
| K931270 | Surgiclean Enzymatic Instrument CleanerFLG · Traditional | 04/13/1994SE |
| K863122 | Assert Biological/Chemical Indicator 12 Month Exp.FRC · Traditional | 12/17/1986SE |
| K855101 | Assert TM Biological/Chemical IndicatorFRC · Traditional | 07/17/1986SE |
| K854902 | Surgicot Steam Test PackFRC · Traditional | 05/20/1986SE |
| K840541 | Neuro SpongeGDY · Traditional | 04/23/1984SE |
| K840471 | Eye SpearHOZ · Traditional | 03/16/1984SE |
| K840470 | Surgiscribe Marking PenFZZ · Traditional | 03/12/1984SE |
| K830739 | Pro-GuardFRG · Traditional | 03/29/1983SE |
| K820302 | Surgipeel Self-Seal Packaging SystemFRG · Traditional | 02/24/1982SE |
Questions and answers
When was Assert Eo Biological Test Pack cleared by the FDA?
Assert Eo Biological Test Pack (K854631) received a 510(k) decision of Substantially Equivalent on May 27, 1986, 190 days after the submission was received.
What is the product code of K854631?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.