510(k) · Cleared
ClearedMoorflpi Full-Field Laser Perfusion 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 Jan 25, 2007 as substantially equivalent to K032841 (Moor Instruments, Ltd., 2003) after a 55-day review. Its family tree reaches back 3 generations to 1991. 6 later devices descend from it.
- Decided
- Jan 25, 2007
- Review
- 55 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. 6 later devices descend from it, 2 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 deviceK063586 Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2007
- Descendant · cites it directly · 3 of its ownK120884 Pericam PsiPerimed AB · 2012
- Descendant · 2 generations on · 1 of its ownK182494 FlowMet-RLaser Associated Sciences, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK122943 Moorflpi-2 Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK233076 Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK192966 FlowMetLaser Associated Sciences, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120884Pericam PsiPerimed AB · 2012 · cites it directly3descendants
- K182494FlowMet-RLaser Associated Sciences, Inc. · 2019 · 2 generations on1descendant
- K122943Moorflpi-2 Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2013 · cites it directly1descendant
- K233076Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd. · 2024 · 2 generations on0descendants
- K192966FlowMetLaser Associated Sciences, Inc. · 2020 · 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) | K063586 | Moorflpi Full-Field Laser Perfusion Imager | Moor Instruments, Ltd. | 2007 | — |
| +1 | K120884 | Pericam Psi | Perimed AB | 2012 | — |
| +2 | K182494 | FlowMet-R | Laser Associated Sciences, Inc. | 2019 | — |
| +1 | K122943 | Moorflpi-2 Full-Field Laser Perfusion Imager | Moor Instruments, Ltd. | 2013 | — |
| +2 | K233076 | Laser Speckle Imaging System (RFLSI CZW) | Rwd Life Science Co., Ltd. | 2024 | — |
| +3 | K192966 | FlowMet | Laser Associated Sciences, Inc. | 2020 | — |
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 |
| 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? (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…Predicate Device: moorLDJ2-IR Jnfrared Laser Doppler Imager 5 10O(k) Number K032841 Moor Irstrtlmonlts~ .td Miilvvoy Axm istor Dvovri FX1 3 -HLJ UK I tl--44 (0129 > tax 123w 1629… | 2003 |
What descends from it? (6)
2 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?
- 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, K120884 (Perimed AB, 2012) has gone furthest, with 3 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 moorFLPI Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063586: Moorflpi Full-Field Laser Perfusion Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063586
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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