510(k) · Cleared
Recalled · Class II · 2026SnapshotGLO (KB100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kent Imaging, Inc. · QJF Autofluorescence Imaging Adjunct Tool For Wounds
Cleared on Mar 26, 2025 as substantially equivalent to K211901 (MolecuLight, Inc., 2021) after a 202-day review. Its family tree reaches back 3 generations to 2018. It has been recalled once.
- Decided
- Mar 26, 2025
- Review
- 202 days
- Class
- Class II
- Product code
- QJF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170092 (2018). No later device cites it as a predicate yet.
- Root · 3 generations backDEN170092 Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control…Fluoptics · 2018
- 2 generations backK191371 MolecuLight i:XMolecuLight, Inc. · 2019
- 1 generation backK211901 MolecuLightDXMolecuLight, Inc. · 2021
- This deviceK242669 SnapshotGLO (KB100)Kent Imaging, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJF device
- #1 K251678 Swift Ray 1score 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211901 | MolecuLightDXSummary page 5…Class II, QJF Tape, Camera, Surgical, 21 CFR 878.4160, Class I, FXN Legally Marketed Predicate Device Device Name: MolecuLightDX 510(k) Number: K211901 SnapshotGLO (KB100) information Indications for Use The SnapshotGLO is a handheld imaging tool that allows clinicians diagnosing… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2026 | Class II | Z-2775-2026 | Software design | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All QJF devicesQJF Autofluorescence Imaging Adjunct Tool For Wounds: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QJF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJF
Too few QJF 510(k)s in any year since 2007 to give a median.
Recalls per year · QJF
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJF
No MAUDE report names QJF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The SnapshotGLO is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to (i) View and digitally record images of a wound, (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase…
Read the full statement (125 words)
The SnapshotGLO is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to
(i) View and digitally record images of a wound,
(ii) Measure and digitally record the size of a wound, and
(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an
excitation light.
The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The SnapshotGLO device should not be used to rule-out the presence of bacteria in a wound.
The SnapshotGLO does not diagnose or treat skin wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242669: SnapshotGLO (KB100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242669
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026