STERRAD CYCLESURE BIOLOGICAL INDICATOR— 510(k) K103222
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K103222 for STERRAD CYCLESURE BIOLOGICAL INDICATOR, Substantially Equivalent on 2011-02-25. Applicant: Advanced Sterilization Products. Device class: 2.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Recent devices under product code FRC
view allMore clearances from Advanced Sterilization Products
view all- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K162007 — STERRAD NX Sterilizer
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
Recalls naming K103222
K-number listed on FDA's recall record- Z-0604-2014 — STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
- Z-0520-2013 — STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.
- Z-2100-2012 — STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103222.
Data sourced from openFDA. This site is unofficial and independent of the FDA.