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SnapshotGLO KB100

by Kent Imaging Inc

SnapshotGLO KB100 (KB100AA) is a Class I device made by Kent Imaging Inc, cleared under FDA 510(k) K242669 on 26 Mar 2025 and listed in FDA GUDID since 10 Jul 2025 (UDI-DI B376KB1000), active as of 23 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

1 ongoing

This device is named in the recall

Documents

510(k) K242669

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 NumberB376KB1000 UDI-DI Date10 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242669 Date26 Mar 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242669 decided 26 Mar 2025 Active
  • FDA GUDID UDI-DI B376KB1000 listed 10 Jul 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2775-2026 FDA Class II initiated 30 Jun 2026

    The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.

Timeline

3 dated events

  1. Cleared FDA 510(k) K242669
  2. Listed FDA GUDID B376KB1000
  3. Recall initiated FDA recalls Z-2775-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SnapshotGLO
Generic name
Fluorescence wound imaging unit
Model / Ref / Catalog
KB100, KB100AA
Primary DI / UDI-DI
B376KB1000
510(k) Number
FDA product code
FXN, QJF
GMDN term
Fluorescence wound imaging unit
Device class
Class I
Regulation number
878.4160, 878.4550
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Fluorescence wound imaging unit

Similar devices

Other devices filed under FDA product code QJF.

Other devices from Kent Imaging Inc

See all devices from Kent Imaging Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)