510(k) · Cleared
ClearedMOORLD12-B1 Laser Doppler Burns Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moor Instruments, Ltd. · DPT Probe, Blood-Flow, Extravascular
Cleared on Mar 27, 2007 as substantially equivalent to K980383 (Moor Instruments, Ltd., 1998) and 1 other predicate after a 351-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Mar 27, 2007
- Review
- 351 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K905232 (1991). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK905232 Moor Laser Blood Flow Monitor MBF3Moor Instruments, Ltd. · 1991
- 2 generations backK980383 Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998
- 1 generation backK032841 Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003
- This deviceK060976 MOORLD12-B1 Laser Doppler Burns ImagerMoor Instruments, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK132163 Moorldls-BI Laser Doppler Burns ImagerMoor Instruments, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132163Moorldls-BI Laser Doppler Burns ImagerMoor Instruments, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905232 | Moor Laser Blood Flow Monitor MBF3 | Moor Instruments, Ltd. | 1991 | — |
| −2 | K980383 | Mooorldi Laser Doppler Imager | Moor Instruments, Ltd. | 1998 | — |
| −1 | K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IR | Moor Instruments, Ltd. | 2003 | — |
| 0 (this device) | K060976 | MOORLD12-B1 Laser Doppler Burns Imager | Moor Instruments, Ltd. | 2007 | — |
| +1 | K132163 | Moorldls-BI Laser Doppler Burns Imager | Moor Instruments, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 DPT? 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 DPT device
- #1 K233076 Laser Speckle Imaging System (RFLSI CZW)score 8.6 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K980383 | Mooorldi Laser Doppler ImagerSummary page 1…moorLDl Laser Doppler Blood Flow Imager 510(k) K980383 moorLDI2-IR Infrared laser Doppler Imager 510(k… | 1998 |
| * | K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRSummary page 1…moorLDI2-IR Infrared laser Doppler Imager 510(k) K032841 Moor Instruments Ltd Miliwey Axmrnster Devon EXS5k-U U… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132163 | Moorldls-BI Laser Doppler Burns Imager | 2014 | 0 |
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 16 years and passes through 1 company; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K132163 (Moor Instruments, Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K980383.
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DPT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DPT
201in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPT
22in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPT
52in 2025
MAUDE reports naming product code DPT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 55 | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 3 | 108 | 0 | 0 |
| 2014 | 3 | 201 | 0 | 5 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 21 |
| 2024 | 1 | — | 22 | 169 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The moorLDl2-BI laser Doppler burns imager assesses the blood flow in debrided burn wounds of the skin. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060976: MOORLD12-B1 Laser Doppler Burns Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060976
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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