510(k) · Cleared
ClearedTM-ABI system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ld Technology, LLC · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Jul 22, 2015 as substantially equivalent to K121108 (Huntleigh Healthcare, 2013) after a 261-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 22, 2015
- Review
- 261 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002186 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002186 Vascular AssistHuntleigh Healthcare, Inc. · 2001 · Recalled
- 1 generation backK121108 Dopplex AbilityHuntleigh Healthcare · 2013
- This deviceK143152 TM-ABI systemLd Technology, LLC · 2015
- Descendant · cites it directly · 2 of its ownK172655 Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2018
- Descendant · 2 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 · 2 generations on · 0 of its ownK191266 VitalScan ANSMedeia, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK173696 TBL-ABI SystemLd Technology, LLC · 2017
Most influential descendants
Showing 4 of 4 · See all- K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2018 · cites it directly2descendants
- K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2020 · 2 generations on0descendants
- K191266VitalScan ANSMedeia, Inc. · 2020 · 2 generations on0descendants
- K173696TBL-ABI SystemLd Technology, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002186 | Vascular Assist | Huntleigh Healthcare, Inc. | 2001 | 1 |
| −1 | K121108 | Dopplex Ability | Huntleigh Healthcare | 2013 | — |
| 0 (this device) | K143152 | TM-ABI system | Ld Technology, LLC | 2015 | — |
| +1 | K172655 | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018 | — |
| +2 | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020 | — |
| +2 | K191266 | VitalScan ANS | Medeia, Inc. | 2020 | — |
| +1 | K173696 | TBL-ABI System | Ld Technology, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121108 | Dopplex AbilitySummary page 4…lassification Name: Hydraulic, pneumatic, or photoelectric plethysmograph Classification Panel: Cardiology 3. Predicate legally marketed devices Dopplex Ability K121108. Applicant: Huntleigh Healthcare Limited – Diagnostic Products Division. Product Code: JOM. 4. Device Description TM-ABI… | 2013 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K172655 (Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd., 2018) has gone furthest, with 2 descendants of its own.
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. 2015, 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?
The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on…
Read the full statement (129 words)
The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care 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.
TM-ABI system can be used on patients with unilateral lower limb amputation.
The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143152: TM-ABI system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143152
Report an extraction error
Are you the manufacturer?
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