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Integrity Sterilizers 270-CR

by Skytron, LLC

Integrity Sterilizers 270-CR 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 10841736100445), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K132439

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841736100445 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132439 Date6 Jan 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132439 decided 6 Jan 2014 Active
  • FDA GUDID UDI-DI 10841736100445 listed 19 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1779-2019 FDA Class II initiated 18 Apr 2019

    Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

Timeline

3 dated events

  1. Cleared FDA 510(k) K132439
  2. Listed FDA GUDID 10841736100445
  3. Recall initiated FDA recalls Z-1779-2019

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Integrity Sterilizers
Generic name
Steam sterilizer
Model / Ref / Catalog
270-CR
Primary DI / UDI-DI
10841736100445
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

Related devices

Category: Steam sterilizer

Cleared under the same submission (K132439)

Similar devices

Other devices filed under FDA product code FLE (Sterilizer, steam).

Other devices from Skytron, LLC

See all devices from Skytron, LLC →

Properties

  • Prescription use
Other properties (14, all answered No)