510(k) · Cleared
ClearedPeriflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF 5010 LDPM Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimed, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on May 28, 1998 as substantially equivalent to K922368 (Perimed, Inc., 1993) and 1 other predicate after a 195-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- May 28, 1998
- Review
- 195 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922368 (1993). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922368 Periflux PF4001 Laser Doppler FlowmeterPerimed, Inc. · 1993
- This deviceK974285 Periflux System 5000 Modular Laser Doppler System Main Unit Model PF…Perimed, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK152930 PeriFlux6000Perimed AB · 2016
- Descendant · cites it directly · 0 of its ownK243852 Elfor-LElfi-Tech, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922368 | Periflux PF4001 Laser Doppler Flowmeter | Perimed, Inc. | 1993 | — |
| 0 (this device) | K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001… | Perimed, Inc. | 1998 | — |
| +1 | K152930 | PeriFlux6000 | Perimed AB | 2016 | — |
| +1 | K243852 | Elfor-L | Elfi-Tech, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 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 DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K922368 | Periflux PF4001 Laser Doppler FlowmeterSummary page 1…F 5001 Main Unit, PF 5010 LDPM Unit, PF 5990 Blank Panel”, PeriSoft Analysis Software and 400-series Probes. Predicate Device: PeriFlux PF 4001 Laser Doppler Flowmeter: K 922368, plus additional probes: K935495. Device description: PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000 consists… | 1993 |
| * | K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2Summary page 1…t, PF 5990 Blank Panel”, PeriSoft Analysis Software and 400-series Probes. Predicate Device: PeriFlux PF 4001 Laser Doppler Flowmeter: K 922368, plus additional probes: K935495. Device description: PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000 consists of a PF 5001 Main Unit, which can… | 1994 |
What descends from it? (2)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K152930 (Perimed AB, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | 1 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.
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/K974285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974285: Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF 5010 LDPM Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974285
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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