510(k) · Cleared
ClearedPeriflux PF4001 Laser Doppler Flowmeter
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 Feb 3, 1993 after a 259-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 3, 1993
- Review
- 259 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK922368 Periflux PF4001 Laser Doppler FlowmeterPerimed, Inc. · 1993
- Descendant · cites it directly · 2 of its ownK974285 Periflux System 5000 Modular Laser Doppler System Main Unit Model PF…Perimed, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK152930 PeriFlux6000Perimed AB · 2016
- Descendant · 2 generations on · 0 of its ownK243852 Elfor-LElfi-Tech, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922368 | Periflux PF4001 Laser Doppler Flowmeter | Perimed, Inc. | 1993 | — |
| +1 | K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001… | Perimed, Inc. | 1998 | — |
| +2 | K152930 | PeriFlux6000 | Perimed AB | 2016 | — |
| +2 | K243852 | Elfor-L | Elfi-Tech, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF… | 1998 | 2 |
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?
- Of its descendants, K974285 (Perimed, Inc., 1998) has gone furthest, with 2 descendants 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 | — |
https://510kreport.com/device/K922368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922368: Periflux PF4001 Laser Doppler Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922368
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026