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SnapshotGLO (KB100)

by Kent Imaging Inc

510(k) K242669

SnapshotGLO (KB100) is a Class II device made by Kent Imaging Inc, cleared under FDA 510(k) K242669 on 26 Mar 2025, active as of 11 Oct 2026. One FDA recall is linked to it.

Active United States

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

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242669 Date26 Mar 2025ClearedStatusActive

Official records

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

2 dated events

  1. Cleared FDA 510(k) K242669
  2. 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  • Withdrawn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

510(k)

510(k) Number
FDA product code
QJF
FDA applicant
Kent Imaging, Inc.
Device class
Class II
Regulation
21 CFR Part 878.4550
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Devices cleared under K242669

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K242669
UDI-DISize and differences
SnapshotGLO KB100
Kent Imaging Inc
KB100AA / KB100B376KB1000 —On the market

Other devices from Kent Imaging Inc

See all devices from Kent Imaging Inc →