FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERRAD NX with ALLClear Technology
K Number: K220404
·
Decision May 16, 2022
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
46
Applicant Total
5
Review Days
91
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Basic Information
- Device Name
- STERRAD NX with ALLClear Technology
- K Number
- K220404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Sterilization Products, Inc.
- Date Received
- February 14, 2022
- Decision Date
- May 16, 2022
- Product Code
- MLR
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MLR | Sterilizer, Chemical | FDA class 2 | General Hospital |
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Other Clearances by Advanced Sterilization Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Apr 15, 2026 | Substantially Equivalent |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | Apr 14, 2025 | Substantially Equivalent |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) | Jul 5, 2024 | Substantially Equivalent |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Oct 9, 2021 | Substantially Equivalent |