510(k) · Cleared
ClearedmoorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler 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 May 12, 2016 as substantially equivalent to K032841 (Moor Instruments, Ltd., 2003) after a 232-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- May 12, 2016
- Review
- 232 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. No later device cites it as a predicate yet.
- 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 deviceK152749 moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High…Moor Instruments, Ltd. · 2016
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) | K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution… | Moor Instruments, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 4…instrument (21 CFR 878.4810, Product Code GEX) Predicate Device: moorLDI2-IR laser Doppler imager 510(k) Number - K032841 Product codes DPT & GEX… | 2003 |
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 25 years and passes through 1 company; a new generation was cleared every 7.3 years on median.
- None of the 4 ancestors has a recall.
- 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. 2016, 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 moorLDI2 Laser Doppler Imager is intended for blood flow measurements in the microcirculation. It is intended to be used for clinical research applications and pre-clinical research applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152749: moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152749
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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