Anprolene SteriTest
FDA 510(k) K170427 · Andersen Sterilizers, Inc.
510(k) numberK170427
Submission
- Device name
- Anprolene SteriTest
- Applicant
- Andersen Sterilizers, Inc.
Haw River, NC, US - Received
- February 13, 2017
- Decision date
- October 31, 2017
- 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 |
|---|---|---|
| K213296 | Anprolene SteriTest RRBIFRC · Traditional | 04/12/2022SE |
| K202879 | EOGas 4 Endo-SteriTest RRBIFRC · Traditional | 03/03/2021SE |
| K200336 | Tyvek Sterilization Pouches with Chevron SealFRG · Traditional | 11/12/2020SE |
| K200335 | Sterisheet Sterilization WrapFRG · Traditional | 11/12/2020SE |
| K200334 | AN1036 DosimeterJOJ · Traditional | 11/12/2020SE |
| K192980 | EOGas 4 Endo-SteriTestFRC · Traditional | 11/12/2020SE |
| K192978 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | 11/12/2020SE |
| K170439 | AN87 DosimeterJOJ · Traditional | 11/01/2017SE |
| K170437 | Sterisheet Sterilization WrapFRG · Traditional | 11/01/2017SE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | 10/31/2017SE |
Questions and answers
When was Anprolene SteriTest cleared by the FDA?
Anprolene SteriTest (K170427) received a 510(k) decision of Substantially Equivalent on October 31, 2017, 260 days after the submission was received.
What is the product code of K170427?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.