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Motorola MBP69SN

by Exclusive Group, LLC

Motorola MBP69SN is a Class II device made by Exclusive Group, LLC, cleared under FDA 510(k) K100488 on 22 Jul 2010 and listed in FDA GUDID since 21 Jul 2017 (UDI-DI 00816479015281), active as of 22 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K100488

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816479015281 UDI-DI Date21 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100488 Date22 Jul 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100488 decided 22 Jul 2010 Active
  • FDA GUDID UDI-DI 00816479015281 listed 21 Jul 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-0689-2018 FDA Class II initiated 2 Feb 2018

    Device may provide inaccurate measurements.

Timeline

3 dated events

  1. Cleared FDA 510(k) K100488
  2. Listed FDA GUDID 00816479015281
  3. Recall initiated FDA recalls Z-0689-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Motorola
Generic name
Infrared patient thermometer, ear
Model / reference
MBP69SN
Primary DI / UDI-DI
00816479015281
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, ear
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, ear

Cleared under the same submission (K100488)

and 8 more cleared under K100488

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

Other devices from Exclusive Group, LLC

Properties

  • Serial number
Other properties (14, all answered No)