510(k) · Cleared
ClearedMoorvms-LDF1 and Moorvms-LDF2 Laser Doppler Perfusion and Temperature Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moor Instruments, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 13, 2009 as substantially equivalent to K011070 (Moor Instruments, Ltd., 2001) after an 89-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jan 13, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011070 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK011070 DRT4 Laser Doppler Perfusion and Temperature MonitorMoor Instruments, Ltd. · 2001
- This deviceK083082 Moorvms-LDF1 and Moorvms-LDF2 Laser Doppler Perfusion and…Moor Instruments, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK112826 Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112826Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011070 | DRT4 Laser Doppler Perfusion and Temperature Monitor | Moor Instruments, Ltd. | 2001 | — |
| 0 (this device) | K083082 | Moorvms-LDF1 and Moorvms-LDF2 Laser Doppler Perfusion and Temperature Monitors | Moor Instruments, Ltd. | 2009 | — |
| +1 | K112826 | Noorvms-Oxy Tissue Oxygen and Temperture Monitor | Moor Instruments, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K011070 | DRT4 Laser Doppler Perfusion and Temperature MonitorSummary page 1…e: DRT4 Laser Doppler perfusion and temperature monitor 510(k) Number K011070 Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK tel i+44 (0)1297 35715 tax +44 (0)1297 35716 email [email protected] we… | 2001 |
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 |
|---|---|---|---|
| K112826 | Noorvms-Oxy Tissue Oxygen and Temperture Monitor | 2012 | 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?
- Its one ancestor has no recall.
- Of its descendants, K112826 (Moor Instruments, Ltd., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083082: Moorvms-LDF1 and Moorvms-LDF2 Laser Doppler Perfusion and Temperature Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083082
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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