510(k) · Cleared
Recalled · Class III · 2025FloPatch (FP120)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flosonics Medical (R/A 1929803 Ontario Corp.) · DPW Flowmeter, Blood, Cardiovascular
Cleared on Mar 24, 2020 as substantially equivalent to K183574 (Huntleigh Healthcare, Ltd., 2019) after a 42-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 24, 2020
- Review
- 42 days
- Class
- Class II
- Product code
- DPW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930200 (1994). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 1 generation backK183574 SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes…Huntleigh Healthcare, Ltd. · 2019
- This deviceK200337 FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2020
- Descendant · cites it directly · 3 of its ownK222242 FloPatch FP120Flosonics Medical · 2022
- Descendant · 2 generations on · 2 of its ownK223843 FloPatch FP120Flosonics Medical · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK251114 FloPatch FP120Flosonics Medical · 2025
- Descendant · 4 generations on · 0 of its ownK252810 FloPatch FP120Flosonics Medical · 2026
Most influential descendants
Showing 4 of 4 · See all- K222242FloPatch FP120Flosonics Medical · 2022 · cites it directly3descendants
- K223843FloPatch FP120Flosonics Medical · 2023 · 2 generations on2descendants
- K251114FloPatch FP120Flosonics Medical · 2025 · 3 generations on1descendant
- K252810FloPatch FP120Flosonics Medical · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −1 | K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare, Ltd. | 2019 | — |
| 0 (this device) | K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020 | — |
| +1 | K222242 | FloPatch FP120 | Flosonics Medical | 2022 | — |
| +2 | K223843 | FloPatch FP120 | Flosonics Medical | 2023 | 1 |
| +3 | K251114 | FloPatch FP120 | Flosonics Medical | 2025 | — |
| +4 | K252810 | FloPatch FP120 | Flosonics Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesSummary page 5…ode (s) Class Regulation Number DMX Handheld Doppler (Primary DPW II 21 CFR 870.2100 Predicate Device) [K183574] Edan Acclarix LX8 Diagnostic IYN, IYO, ITX II 21 CFR 892.1550 Ultrasound System (Referenc… | 2019 |
| † | K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | 2018 |
| † | K191388 | FloPatch (FP110) | 2019 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222242 | FloPatch FP120 | 2022 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2025 | Class III | Z-2517-2025 | Labeling Change Control | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 25.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K222242 (Flosonics Medical, 2022) has gone furthest, with 3 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. 2020, 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 FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.
The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200337: FloPatch (FP120).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200337
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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