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.
Clearance details
- Applicant
- Advanced Sterilization Products, Inc.
- Product code
- 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
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- K233065 — V-PRO maX 2 Low Temperature Sterilization 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.