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Sterrad™ 10144

by Advanced Sterilization Products Services Inc.

Ref 10144

Sterrad™ 10144 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 0705037A140000000000014NZ), cleared under FDA 510(k) K234082 on 5 Jul 2024 (5 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10705037014903), active as of 23 Oct 2026. 8 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

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K234082

+5 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705037A140000000000014NZ Basic UDI-DI 10705037014903UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK234082 Date5 Jul 2024DecidedStatusActive
United StatesGUDID listing GUDID Number10705037014903 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705037A140000000000014NZ registered 16 Apr 2026 Active
  • FDA 510(k) K234082 decided 5 Jul 2024 Active· +5 more in the status table
  • FDA GUDID UDI-DI 10705037014903 listed 24 Sep 2016 Listed

Recalls

8 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-0846-2015 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-0402-2014 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-0044-2014 FDA Class II initiated 18 Sep 2013

    Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.

    • Terminated Z-2174-2013 FDA Class II initiated 25 Jul 2013

    The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.

    • Terminated Z-1026-2013 FDA Class II initiated 22 Mar 2013

    The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

    • Terminated Z-1632-2008 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."

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-0044-2014
  2. Recall initiated FDA recalls Z-0402-2014
  3. Recall initiated FDA recalls Z-0846-2015
  4. Recall initiated FDA recalls Z-2375-2015
  5. Listed FDA GUDID 10705037014903
  6. Cleared FDA 510(k) K160903
  7. Recall initiated FDA recalls Z-1197-2017
  8. Cleared FDA 510(k) K212174
  9. Cleared FDA 510(k) K234082
  10. Registered EUDAMED 0705037A140000000000014NZ

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™ 100NX Cassette EUDAMED
Sterrad™ GUDID
Generic name
Hydrogen peroxide device sterilant
Model / Ref / Catalog
10144
Primary DI / UDI-DI
10705037014903
Basic UDI-DI
0705037A140000000000014NZ
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 (K092622)

Cleared under the same submission (K111377)

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)