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Ahto 0250070601

by Stryker Corp.

Ahto 0250070601 is a surgical irrigation/aspiration pump (FDA Class II) made by Stryker Corp., cleared under FDA 510(k) K042454 on 9 Dec 2004 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 07613327052138), active as of 23 Oct 2026. 5 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

3 ongoing

This device is named in the recall

Documents

510(k) K042454

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 Number07613327052138 UDI-DI Date22 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042454 Date9 Dec 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042454 decided 9 Dec 2004 Active
  • FDA GUDID UDI-DI 07613327052138 listed 22 Aug 2016 Listed

Recalls

5 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2864-2026 FDA Class II initiated 8 Jun 2026
    • Ongoing Z-2863-2026 FDA Class II initiated 8 Jun 2026
    • Ongoing Z-2862-2026 FDA Class II initiated 8 Jun 2026

    There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

    • Terminated Z-0836-2018 FDA Class II initiated 17 Nov 2017

    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

    • Terminated Z-0279-06 FDA Unclassified (pre-2012) initiated 18 Nov 2005

    Devices for which sterility may be compromised as evidenced by a crack in the package.

Timeline

7 dated events

  1. Cleared FDA 510(k) K042454
  2. Recall initiated FDA recalls Z-0279-06
  3. Listed FDA GUDID 07613327052138
  4. Recall initiated FDA recalls Z-0836-2018
  5. Recall initiated FDA recalls Z-2864-2026
  6. Recall initiated FDA recalls Z-2863-2026
  7. Recall initiated FDA recalls Z-2862-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ahto
Generic name
Surgical irrigation/aspiration pump, reusable
Model / Ref / Catalog
0250070601
Primary DI / UDI-DI
07613327052138
510(k) Number
FDA product code
GCX, HET, KQT
GMDN term
Surgical irrigation/aspiration pump, reusable
Device class
Class II
Regulation number
880.6740, 884.1720, 876.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical irrigation/aspiration pump, reusable

Cleared under the same submission (K042454)

Similar devices in this category

Other devices filed under Surgical irrigation/aspiration pump, reusable.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)