STERRAD 100NX Sterilization System with ALLClear Technology (10104)— 510(k) K252843
Substantially EquivalentAdvanced Sterilization Products, Inc.
FDA 510(k) clearance K252843 for STERRAD 100NX Sterilization System with ALLClear Technology (10104), Substantially Equivalent on 2026-04-15. Applicant: Advanced Sterilization Products, Inc.. Device class: 2.
Summary
Advanced Sterilization Products' STERRAD 100NX Sterilization System with ALLClear Technology (10104) is filed under product code MLR (Sterilizer, Chemical). The record doesn't explain the ALLClear Technology in the device name.
Class II, 21 CFR 880.6860. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Advanced Sterilization Products filed from Irvin, California. The decision came 219 calendar days after FDA received it (September 8, 2025 to April 15, 2026).
Clearance details
- Applicant
- Advanced Sterilization Products, Inc.
- Product code
- Product code MLR
- Device class
- Class 2
- Regulation
- 21 CFR 880.6860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Recent devices under product code MLR
view all- K263530 — V-Pro maX 2 Low Temperature Sterilization System
- K250802 — STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
- K231893 — LOWTEM Crystal 120
- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
- K233762 — SteroScope® Sterilization Technology System
More clearances from Advanced Sterilization Products, Inc.
view allAdverse events under product code MLR
product code MLR- Malfunction
- 805
- Total
- 805
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.