510(k) · Cleared
ClearedPeriFlux6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimed AB · DPW Flowmeter, Blood, Cardiovascular
Cleared on May 5, 2016 as substantially equivalent to K974285 (Perimed, Inc., 1998) and 2 other predicates after a 213-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- May 5, 2016
- Review
- 213 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922368 (1993). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922368 Periflux PF4001 Laser Doppler FlowmeterPerimed, Inc. · 1993
- 1 generation backK974285 Periflux System 5000 Modular Laser Doppler System Main Unit Model PF…Perimed, Inc. · 1998
- This deviceK152930 PeriFlux6000Perimed AB · 2016
- Descendant · cites it directly · 0 of its ownK243852 Elfor-LElfi-Tech, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243852Elfor-LElfi-Tech, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF…Summary page 4…PM Unit PF 5020 Temp Unit PF 5050 Pressure Unit 510(k) No: K974285, K932068, K011899 Type of product: Finished product Panel: Cardiovascular Predic… | 1998 |
| * | K932068 | Peritemp PF 4005 HeaterSummary page 4…PF 5020 Temp Unit PF 5050 Pressure Unit 510(k) No: K974285, K932068, K011899 Type of product: Finished product Panel: Cardiovascular Predicate devic… | 1993 |
| * | K011899 | PF 5050 Pressure Unit, Model PF 5050Summary page 4…PF 5020 Temp Unit PF 5050 Pressure Unit 510(k) No: K974285, K932068, K011899 Type of product: Finished product Panel: Cardiovascular Predicate device No 2 Tr… | 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 |
|---|---|---|---|
| K243852 | Elfor-L | 2025 | 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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 17.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K243852 (Elfi-Tech, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K974285.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
PeriFlux 6000 equipped with PF 6010 is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is also intended for measuring micro-vascular perfusion in all tissues in animals for research purposes. The PF 6010 is also intended for evaluating tissue response in skin to local heating and providing temperature stabilization of skin at blood perfusion measurement. PeriFlux 6000 equipped with PF 6050 is intended for measuring the…
Read the full statement (168 words)
PeriFlux 6000 equipped with PF 6010 is intended for measuring micro-vascular perfusion in skin and muscle in humans.
It is also intended for measuring micro-vascular perfusion in all tissues in animals for research purposes.
The PF 6010 is also intended for evaluating tissue response in skin to local heating and providing temperature
stabilization of skin at blood perfusion measurement.
PeriFlux 6000 equipped with PF 6050 is intended for measuring the pressure in blood pressure cuffs, to simplify
simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor.
PeriFlux 6000 equipped with PF 6050 is also intended for Pulse Volume Recording (PVR) on human limbs and digits for
diagnosis and evaluation of vascular disease in adults. It is not intended for use on neonates and pregnant women.
PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial
pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas
anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152930: PeriFlux6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152930
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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