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Microtek 1

by Microtek Medical LLC 1,000+ variants

Microtek 1 is a Class II device made by Microtek Medical LLC, cleared under FDA 510(k) K882724 on 3 Aug 1988 and listed in FDA GUDID since 27 Jan 2017 (UDI-DI 00748426120956), active as of 23 Oct 2026. 8 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

510(k) K882724

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 Number00748426120956 UDI-DI Date27 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK882724 Date3 Aug 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K882724 decided 3 Aug 1988 Active
  • FDA GUDID UDI-DI 00748426120956 listed 27 Jan 2017 Listed

Recalls

8 recalls · FDA

    • Terminated Z-0753-2017 FDA Class III initiated 30 Nov 2016

    The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.

    • Terminated Z-0974-2014 FDA Class II initiated 12 Jul 2013

    No endotoxin (LAL) testing to proper level.

  • 6 recalls, same reason

    • Terminated Z-0947-2014 FDA Class II initiated 2 Jul 2013
    • Terminated Z-0946-2014 FDA Class II initiated 2 Jul 2013
    • Terminated Z-0945-2014 FDA Class II initiated 2 Jul 2013
    • Terminated Z-0944-2014 FDA Class II initiated 2 Jul 2013
    • Terminated Z-0948-2014 FDA Class II initiated 2 Jul 2013
    • Terminated Z-0943-2014 FDA Class II initiated 2 Jul 2013

    Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Timeline

10 dated events

  1. Cleared FDA 510(k) K882724
  2. Recall initiated FDA recalls Z-0947-2014
  3. Recall initiated FDA recalls Z-0946-2014
  4. Recall initiated FDA recalls Z-0945-2014
  5. Recall initiated FDA recalls Z-0944-2014
  6. Recall initiated FDA recalls Z-0948-2014
  7. Recall initiated FDA recalls Z-0943-2014
  8. Recall initiated FDA recalls Z-0974-2014
  9. Recall initiated FDA recalls Z-0753-2017
  10. Listed FDA GUDID 00748426120956

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Microtek
Generic name
Body-orifice ultrasound imaging transducer cover, basic, non-sterile
Model / reference
1
Primary DI / UDI-DI
00748426120956
510(k) Number
FDA product code
KKX
GMDN term
Body-orifice ultrasound imaging transducer cover, basic, non-sterile
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Body-orifice ultrasound imaging transducer cover, basic, non-sterile

Cleared under the same submission (K882724)

and 8 more cleared under K882724

Other devices from Microtek Medical LLC

See all devices from Microtek Medical LLC →

Properties

  • Single use
  • Contains latex
  • Lot / batch number
Other properties (12, all answered No)