510(k) · Cleared
ClearedLaminar P1 (LDH-HW-001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laminar Digital Health, Inc. · JAF Monitor, Ultrasonic, Nonfetal
Cleared on Dec 13, 2024 as substantially equivalent to K191388 (Flosonics Medical (R/A 1929803 Ontario Corp.), 2019) after a 114-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Dec 13, 2024
- Review
- 114 days
- Class
- Class II
- Product code
- JAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930200 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 6 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 5 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 4 generations backK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- 3 generations backK101960 Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2010
- 2 generations backK140579 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2015
- 1 generation backK191388 FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2019
- This deviceK242487 Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −6 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −5 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −4 | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| −3 | K101960 | Sonotrax Series Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2010 | — |
| −2 | K140579 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2015 | — |
| −1 | K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019 | — |
| 0 (this device) | K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 JAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K191388 | FloPatch (FP110)Summary page 5…Predicate Device Name / Manufacturer Primary Predicate K191388 FloPatch (FP110) / Flosonics Medical ✓ The predicate device has not been subject to… | 2019 |
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 30 years and passes through 6 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All JAF devicesJAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JAF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAF
Too few JAF 510(k)s in any year since 2007 to give a median.
Recalls per year · JAF
No recall names JAF since 2007.
Adverse event reports per year · JAF
1in 2023
MAUDE reports naming product code JAF, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 44 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242487: Laminar P1 (LDH-HW-001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242487
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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