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S40 S4000

by Steris Corporation

S40 S4000 is a Class II device made by Steris Corporation, cleared under FDA 510(k) K251666 on 8 Apr 2026 (20 earlier submissions) and listed in FDA GUDID since 8 Sep 2016 (UDI-DI 00724995090722), active as of 22 Oct 2026. 6 FDA recalls are 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

8 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251666 Date8 Apr 2026DecidedStatusActive
United StatesGUDID listing Number00724995090722 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251666 decided 8 Apr 2026 Active· +20 more in the status table
  • FDA GUDID UDI-DI 00724995090722 listed 8 Sep 2016 Listed

Recalls

8 recalls · FDA

    • Terminated Z-1180-2016 FDA Class II initiated 4 Dec 2015

    The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.

    • Terminated Z-0616-2014 FDA Class II initiated 21 Nov 2013 on shared 510(k) K090036

    Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.

    • Terminated Z-1596-2013 FDA Class II initiated 4 Mar 2013

    During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.

    • Terminated Z-2284-2012 FDA Class II initiated 10 Aug 2012

    STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..

    • Terminated Z-2335-2012 FDA Class II initiated 1 Aug 2012

    The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.

    • Terminated Z-0869-2012 FDA Unclassified (pre-2012) initiated 7 Dec 2011

    Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteriae may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which

    • Terminated Z-3124-2011 FDA Unclassified (pre-2012) initiated 11 Aug 2011 on shared 510(k) K090036

    STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.

    • Terminated Z-1960-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011

    The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to inco

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

30 dated events

  1. Cleared FDA 510(k) K191343
  2. Cleared FDA 510(k) K192929
  3. Cleared FDA 510(k) K210737
  4. Cleared FDA 510(k) K211607
  5. Cleared FDA 510(k) K222615
  6. Cleared FDA 510(k) K230582
  7. Cleared FDA 510(k) K230930
  8. Cleared FDA 510(k) K232914
  9. Cleared FDA 510(k) K243433
  10. Cleared FDA 510(k) K251666

20 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
S40
Generic name
Organic peroxy acid device sterilant, single-use
Model / Ref / Catalog
S4000
Primary DI / UDI-DI
00724995090722
510(k) Number
FDA product code
MED, FEB
GMDN term
Organic peroxy acid device sterilant, single-use
Device class
Class II
Regulation number
880.6885, 876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Organic peroxy acid device sterilant, single-use

Cleared under the same submission (K090036)

and 8 more cleared under K090036

Cleared under the same submission (K101409)

and 8 more cleared under K101409

Similar devices

Other devices filed under FDA product code MED (Sterilant, medical devices).

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)