510(k) · Cleared
ClearedDopplex Ability
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Jan 3, 2013 as substantially equivalent to K002186 (Huntleigh Healthcare, Inc., 2001) after a 266-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Jan 3, 2013
- Review
- 266 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002186 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002186 Vascular AssistHuntleigh Healthcare, Inc. · 2001 · Recalled
- This deviceK121108 Dopplex AbilityHuntleigh Healthcare · 2013
- Descendant · cites it directly · 4 of its ownK143152 TM-ABI systemLd Technology, LLC · 2015
- Descendant · 2 generations on · 2 of its ownK172655 Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK201046 Automated ankle brachial pressure index measuring device, MESI…Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK191266 VitalScan ANSMedeia, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK173696 TBL-ABI SystemLd Technology, LLC · 2017
Most influential descendants
Showing 5 of 5 · See all- K143152TM-ABI systemLd Technology, LLC · 2015 · cites it directly4descendants
- K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2018 · 2 generations on2descendants
- K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2020 · 3 generations on0descendants
- K191266VitalScan ANSMedeia, Inc. · 2020 · 3 generations on0descendants
- K173696TBL-ABI SystemLd Technology, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002186 | Vascular Assist | Huntleigh Healthcare, Inc. | 2001 | 1 |
| 0 (this device) | K121108 | Dopplex Ability | Huntleigh Healthcare | 2013 | — |
| +1 | K143152 | TM-ABI system | Ld Technology, LLC | 2015 | — |
| +2 | K172655 | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018 | — |
| +3 | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020 | — |
| +3 | K191266 | VitalScan ANS | Medeia, Inc. | 2020 | — |
| +2 | K173696 | TBL-ABI System | Ld Technology, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 JOM? 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 JOM device
- #1 K220527 PADnet Xpressscore 5.1 · 4 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 |
|---|---|---|---|
| * | K002186 | Vascular AssistSummary page 1…JOM 870.2780 Classification Name: Hydraulic, pneumatic, or photoelectric plethysmographs Predicate Device: Vascular Assist (K002186) manufactured by Huntleigh Healthcare Limited, 35 Portmanmoor Road, Cardiff, CF24 SHN, UK Indicatio… | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143152 | TM-ABI system | 2015 | 4 |
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?
How does its category compare?
All JOM devicesJOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JOM
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JOM
Too few JOM 510(k)s in any year since 2007 to give a median.
Recalls per year · JOM
No recall names JOM since 2007.
Adverse event reports per year · JOM
1in 2007
MAUDE reports naming product code JOM, 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 | 2 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Dopplex Ability is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
Dopplex Ability is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography.
It is suitable for use in woundcare assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. Dopplex Ability can be used on patients with unilateral lower limb amputation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121108 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121108: Dopplex Ability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121108
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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