FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
K Number: K231488
·
Decision Aug 7, 2023
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
21
Review Days
76
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Basic Information
- Device Name
- Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
- K Number
- K231488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Steris
- Date Received
- May 23, 2023
- Decision Date
- August 7, 2023
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by Steris
| K Number | Device Name | ||
|---|---|---|---|
| DEN240075 | Prolystica Pass Thru Disinfectant Wipes | May 1, 2026 | Unknown |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Jun 6, 2025 | Substantially Equivalent |
| K242773 | Electro Lube NXT | Apr 15, 2025 | Substantially Equivalent |
| DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | Nov 12, 2024 | Unknown |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Aug 20, 2024 | Substantially Equivalent |
| K241344 | MetriCide OPA Plus Solution Test Strip | Jun 11, 2024 | Substantially Equivalent |
| K241055 | Electro Lube NXT | May 31, 2024 | Substantially Equivalent |
| K240760 | CELERITY HP Indicator Tape | Apr 10, 2024 | Substantially Equivalent |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | Mar 8, 2024 | Substantially Equivalent |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | Dec 8, 2023 | Substantially Equivalent |