K252843
- 510(k) number
- K252843
- Device name
- STERRAD 100NX Sterilization System with ALLClear Technology (10104)
- Applicant
- Advanced Sterilization Products, Inc. CA · US
- Product code
- MLR — Sterilizer, Chemical
- Decision date
- 2026-04-15
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K252843.pdf
Official FDA record: K252843
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.