510(k) · Cleared
ClearedElfor-L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elfi-Tech, Ltd. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Apr 14, 2025 as substantially equivalent to K974285 (Perimed, Inc., 1998) and 1 other predicate after a 119-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Apr 14, 2025
- Review
- 119 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922368 (1993). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK922368 Periflux PF4001 Laser Doppler FlowmeterPerimed, Inc. · 1993
- 2 generations backK974285 Periflux System 5000 Modular Laser Doppler System Main Unit Model PF…Perimed, Inc. · 1998
- 1 generation backK152930 PeriFlux6000Perimed AB · 2016
- This deviceK243852 Elfor-LElfi-Tech, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922368 | Periflux PF4001 Laser Doppler Flowmeter | Perimed, Inc. | 1993 | — |
| −2 | K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001… | Perimed, Inc. | 1998 | — |
| −1 | K152930 | PeriFlux6000 | Perimed AB | 2016 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF…Summary page 5…PW III. PREDICATE DEVICE ELFI-TECH Ltd. believes that Elfor-L is substantially equivalent to the following predicate device: • Perimed Inc. PeriFlux 5000 cleared under K974285, Product code DPW, Regulation number 21 CFR 870.2100 and in subsequent submission under K152930, PeriFlux 6000, Product code… | 1998 |
| * | K152930 | PeriFlux6000Summary page 5…following predicate device: • Perimed Inc. PeriFlux 5000 cleared under K974285, Product code DPW, Regulation number 21 CFR 870.2100 and in subsequent submission under K152930, PeriFlux 6000, Product code DPW, Regulation number 21 CFR 870.2100. IV. DEVICE DESCRIPTION The Elfor-L device is making use… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 7 ancestors has a recall.
- 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. 2025, 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?
The Elfor L is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is intended to be used for
clinical research applications and pre clinical research applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243852: Elfor-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243852
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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