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STERIS 5085 SRT Surgical Table

by Steris Corporation 2 variants

Ref 413724629Model 5085 SRT Surgical Table

STERIS 5085 SRT Surgical Table (413724629) is a universal operating table (EU MDR Class I; FDA Class I; FDA product code FQO, Table, Operating-Room, Ac-Powered) made by Steris Corporation, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI 0724995MG5085SRTSGTBL6L), cleared under FDA 510(k) K090136 on 20 Mar 2009 and listed in FDA GUDID since 31 Mar 2021 (UDI-DI 00724995155551), active as of 24 Oct 2026. 2 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

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090136

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MG5085SRTSGTBL6L Basic UDI-DI 00724995155551UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995155551 UDI-DI Date31 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090136 Date20 Mar 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995MG5085SRTSGTBL6L registered 16 Sep 2026 Active
  • FDA 510(k) K090136 decided 20 Mar 2009 Active
  • FDA GUDID UDI-DI 00724995155551 listed 31 Mar 2021 Listed

Recalls

4 recalls · FDA

    • Terminated Z-0196-2015 FDA Class II initiated 10 Oct 2014 on shared 510(k) K090136

    The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.

    • Terminated Z-2426-2012 FDA Class II initiated 6 Apr 2012 on shared 510(k) K090136

    STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlock

    • Terminated Z-0279-2012 FDA Unclassified (pre-2012) initiated 17 Oct 2011

    Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.

    • Terminated Z-1941-2010 FDA Unclassified (pre-2012) initiated 14 May 2010

    STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table

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

Timeline

7 dated events

  1. Cleared FDA 510(k) K090136
  2. Recall initiated FDA recalls Z-1941-2010
  3. Recall initiated FDA recalls Z-0279-2012
  4. Recall initiated FDA recalls Z-2426-2012
  5. Recall initiated FDA recalls Z-0196-2015
  6. Listed FDA GUDID 00724995155551
  7. Registered EUDAMED 0724995MG5085SRTSGTBL6L

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
Steris
Generic name
Universal operating table, electromechanical
Model / Ref / Catalog
5085 SRT Surgical Table, 413724629
Primary DI / UDI-DI
00724995155551
Basic UDI-DI
0724995MG5085SRTSGTBL6L
510(k) Number
FDA product code
FQO
EMDN code
Z12011202 Operating tables
GMDN term
Universal operating table, electromechanical
Device class
Class I
Regulation number
878.4960
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Universal operating table, electromechanical

Cleared under the same submission (K090136)

and 2 more cleared under K090136

Similar devices in this category

Other devices filed under OPERATING TABLES.

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)