510(k) · Cleared
ClearedSwift Ray 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swift Medical, Inc. · QJF Autofluorescence Imaging Adjunct Tool For Wounds
Cleared on Feb 24, 2026 as substantially equivalent to K191371 (MolecuLight, Inc., 2019) and 1 other predicate after a 270-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Feb 24, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- QJF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K070426 (2007). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070426 | Silhouette, Model 1000.01 | Aranz Medical Limited | 2007 | — |
| −1 | K131596 | Wound Measuring & Monitoring Device | Woundvision, LLC | 2013 | — |
| 0 (this device) | K251678 | Swift Ray 1 | Swift Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
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 K242669 SnapshotGLO (KB100)score 7.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K191371 | MolecuLight i:XSummary page 5…me: Autofluorescence Imaging Adjunct Tool For Wounds Regulation Number: 878.4550 Product Code(s): QJF, FXN Legally Marketed Predicate Device Predicate Device Number: K191371 Predicate Device Trade Name: MolecuLight i:X Product Code: QJF, FXN Secondary predicate Device Secondary Pre… | 2019 |
| * | K131596 | Wound Measuring & Monitoring DeviceSummary page 6…ce Number: K191371 Predicate Device Trade Name: MolecuLight i:X Product Code: QJF, FXN Secondary predicate Device Secondary Predicate Device Number: K131596 Secondary Predicate Device Trade Name: WoundVision Scout Product Code: FXN Device Description Summary The Swift Ray 1 is a p… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K191371.
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. 2026, 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 Swift Ray 1 is a portable digital imaging device that allow clinicians diagnosing and treating wounds, at the point of care, to: i. View and digitally record images of a wound, ii. Digitally measure and record the size of the wound iii. View and record digital images of fluorescence emitted from the wound when exposed to an excitation light, and iv. View and record thermographic images and measure temperature differences within the image using…
Read the full statement (148 words)
The Swift Ray 1 is a portable digital imaging device that allow clinicians diagnosing and treating wounds, at the point of care, to:
i. View and digitally record images of a wound,
ii. Digitally measure and record the size of the wound
iii. View and record digital images of fluorescence emitted from the wound when exposed to an excitation light, and
iv. View and record thermographic images and measure temperature differences within the image using long-wave infrared technology
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 >10^4 CFU per gram as compared to examination of clinical signs and symptoms alone.
The Swift Ray 1 device should not be used to rule-out the presence of bacteria in a wound.
The Swift Ray 1 does not diagnose or treat skin wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251678: Swift Ray 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251678
Report an extraction error
Are you the manufacturer?
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