Integrity Sterilizers INTEGRITY 270VP
by Skytron, LLC
Integrity Sterilizers INTEGRITY 270VP is a Class II device made by Skytron, LLC, cleared under FDA 510(k) K132439 on 6 Jan 2014 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 10841736100131), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10841736100131 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132439 | Date6 Jan 2014 | StatusActive |
Official records
- AccessGUDID record 10841736100131
- FDA 510(k) database K132439
Across registries
- FDA 510(k) K132439 decided 6 Jan 2014 Active
- FDA GUDID UDI-DI 10841736100131 listed 19 Sep 2016 Listed
Recalls
-
- Terminated Z-1779-2019
Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
Timeline
- Cleared FDA 510(k) K132439
- Listed FDA GUDID 10841736100131
- Recall initiated FDA recalls Z-1779-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integrity Sterilizers
- Generic name
- Steam sterilizer
- Model / Ref / Catalog
- INTEGRITY 270VP
- Primary DI / UDI-DI
- 10841736100131
- 510(k) Number
- FDA product code
- FLE
- GMDN term
- Steam sterilizer
- Device class
- Class II
- Regulation number
- 880.6880
- GUDID distribution status
- In Commercial Distribution
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