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Sterrad™ 10133

by Advanced Sterilization Products Services Inc.

Ref 10133

Sterrad™ 10133 is a device classified as Class IIa in the EU and Class II in the US made by Advanced Sterilization Products Services Inc., registered in EUDAMED on 16 Apr 2026 (Basic UDI-DI 0705037A130000000000013ML), cleared under FDA 510(k) K220404 on 16 May 2022 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10705037014835), active as of 23 Oct 2026. 11 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

11 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220404

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705037A130000000000013ML Basic UDI-DI 10705037014835UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220404 Date16 May 2022DecidedStatusActive
United StatesGUDID listing GUDID Number10705037014835 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705037A130000000000013ML registered 16 Apr 2026 Active
  • FDA 510(k) K220404 decided 16 May 2022 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10705037014835 listed 24 Sep 2016 Listed

Recalls

11 recalls · FDA

    • Terminated Z-1197-2017 FDA Class II initiated 9 Jan 2017

    Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.

    • Terminated Z-2375-2015 FDA Class II initiated 17 Jul 2015

    Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."

    • Terminated Z-0845-2015 FDA Class II initiated 4 Nov 2014

    Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

    • Terminated Z-0744-2014 FDA Class II initiated 16 Dec 2013

    Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

    • Terminated Z-0403-2014 FDA Class II initiated 11 Nov 2013

    Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.

    • Terminated Z-2338-2012 FDA Class III initiated 19 Jun 2012

    Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.

    • Terminated Z-1420-2009 FDA Unclassified (pre-2012) initiated 9 Mar 2009

    ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs.

    • Terminated Z-0468-2012 FDA Unclassified (pre-2012) initiated 10 Dec 2008

    Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot #08I032 were printed improperly and are not capable of being read by the STERRAD unit.

    • Terminated Z-0484-2009 FDA Unclassified (pre-2012) initiated 7 Oct 2008

    ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings.

    • Terminated Z-1631-2008 FDA Unclassified (pre-2012) initiated 25 Feb 2008

    Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."

    • Terminated Z-0844-2008 FDA Unclassified (pre-2012) initiated 12 Nov 2007

    Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-2338-2012
  2. Recall initiated FDA recalls Z-0403-2014
  3. Recall initiated FDA recalls Z-0744-2014
  4. Recall initiated FDA recalls Z-0845-2015
  5. Recall initiated FDA recalls Z-2375-2015
  6. Listed FDA GUDID 10705037014835
  7. Cleared FDA 510(k) K160818
  8. Recall initiated FDA recalls Z-1197-2017
  9. Cleared FDA 510(k) K220404
  10. Registered EUDAMED 0705037A130000000000013ML

6 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
STERRAD NX™ Cassette EUDAMED
Sterrad™ GUDID
Generic name
Hydrogen peroxide device sterilant
Model / Ref / Catalog
10133
Primary DI / UDI-DI
10705037014835
Basic UDI-DI
0705037A130000000000013ML
510(k) Number
FDA product code
MLR
EMDN code
S900101 Hydrogen peroxide cartridges
GMDN term
Hydrogen peroxide device sterilant
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6860
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Hydrogen peroxide device sterilant

Cleared under the same submission (K142454)

Cleared under the same submission (K160818)

Similar devices in this category

Other devices filed under HYDROGEN PEROXIDE CARTRIDGES.

Other devices from Advanced Sterilization Products, Inc.

See all devices from Advanced Sterilization Products, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)