510(k) · Cleared
ClearedMoorldls Laser Doppler Line Scanner
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 Jan 19, 2007 as substantially equivalent to K032841 (Moor Instruments, Ltd., 2003) after a 53-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- Jan 19, 2007
- Review
- 53 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905232 (1991). 4 ancestors in all. 3 later devices descend 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 deviceK063561 Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK121429 Aimago Easyldi Microcirculation CameraAimago SA · 2012
- Descendant · 2 generations on · 1 of its ownK123216 Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm)…Aimago SA · 2013
- Descendant · 3 generations on · 0 of its ownK163339 Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K121429Aimago Easyldi Microcirculation CameraAimago SA · 2012 · cites it directly2descendants
- K123216Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…Aimago SA · 2013 · 2 generations on1descendant
- K163339Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc. · 2017 · 3 generations on0descendants
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) | K063561 | Moorldls Laser Doppler Line Scanner | Moor Instruments, Ltd. | 2007 | — |
| +1 | K121429 | Aimago Easyldi Microcirculation Camera | Aimago SA | 2012 | — |
| +2 | K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy… | Aimago SA | 2013 | — |
| +3 | K163339 | Spectralmd Deepview Wound Imaging System 2.0 | Spectralmd, Inc. | 2017 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRSummary page 1…edicate Device: moorLDJ2-IR Infrared Laser Doppler Imager 5 10(k) Number K032841 Moor Instruments Ltd Mitwey Axminster Devon EX13 5HU UK tel +44 (0)1297 35715 fax +44 (0)1297 35716 email [email protected] webs… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121429 | Aimago Easyldi Microcirculation Camera | 2012 | 2 |
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, K121429 (Aimago SA, 2012) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K032841.
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 moorLDLS Laser Doppler Line Scanner is intended for blood flow measurements in the microcirculation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063561 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063561: Moorldls Laser Doppler Line Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063561
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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