510(k) · Cleared
ClearedMooorldi 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 Apr 30, 1998 as substantially equivalent to K920844 (Lisca Development AB, 1992) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1991. 16 later devices descend from it.
- Decided
- Apr 30, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905232 (1991). 2 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK905232 Moor Laser Blood Flow Monitor MBF3Moor Instruments, Ltd. · 1991
- This deviceK980383 Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998
- Descendant · cites it directly · 15 of its ownK032841 Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003
- Descendant · 2 generations on · 6 of its ownK063586 Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2007
- Descendant · 3 generations on · 3 of its ownK120884 Pericam PsiPerimed AB · 2012
- Descendant · 2 generations on · 3 of its ownK063561 Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK121429 Aimago Easyldi Microcirculation CameraAimago SA · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K032841Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003 · cites it directly15descendants
- K063586Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2007 · 2 generations on6descendants
- K120884Pericam PsiPerimed AB · 2012 · 3 generations on3descendants
- K063561Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd. · 2007 · 2 generations on3descendants
- K121429Aimago Easyldi Microcirculation CameraAimago SA · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905232 | Moor Laser Blood Flow Monitor MBF3 | Moor Instruments, Ltd. | 1991 | — |
| 0 (this device) | K980383 | Mooorldi Laser Doppler Imager | Moor Instruments, Ltd. | 1998 | — |
| +1 | K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IR | Moor Instruments, Ltd. | 2003 | — |
| +2 | K063586 | Moorflpi Full-Field Laser Perfusion Imager | Moor Instruments, Ltd. | 2007 | — |
| +3 | K120884 | Pericam Psi | Perimed AB | 2012 | — |
| +2 | K063561 | Moorldls Laser Doppler Line Scanner | Moor Instruments, Ltd. | 2007 | — |
| +2 | K121429 | Aimago Easyldi Microcirculation Camera | Aimago SA | 2012 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K920844 | Pim 1.0 Laser Doppler Perfusion ImagerSummary page 2…0.10 and 1040.11 as a Class IITa Medical Laser Product. Performance Standard: Reason for Submission: New Device PIM 1.0 Laser Doppler Perfusion Imager 510(k) Number - K920844 Predicate Devices: Moor Laser Blood Flow Monitor MBF3D 510(k) Number - K905232 Description of the Device The moorLDI laser Do… | 1992 |
| * | K905232 | Moor Laser Blood Flow Monitor MBF3Summary page 2…eason for Submission: New Device PIM 1.0 Laser Doppler Perfusion Imager 510(k) Number - K920844 Predicate Devices: Moor Laser Blood Flow Monitor MBF3D 510(k) Number - K905232 Description of the Device The moorLDI laser Doppler imager is a device for imaging blood flow in the microcirculation of surfac… | 1991 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 moorLDI Laser Doppler Imager is intended for studies of blood flow in the
microcirculation, e.g. blood flow in the small blood vessels of the skin. It is suitable for a
wide range of clinical research applications including plastic surgery, diabetes,
dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and
anaesthetics.
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/K980383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980383: Mooorldi 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/K980383
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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