510(k) · Cleared
ClearedAutomated ankle brachial pressure index measuring device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Jan 11, 2018 as substantially equivalent to K143152 (Ld Technology, LLC, 2015) after a 128-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 11, 2018
- Review
- 128 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002186 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002186 Vascular AssistHuntleigh Healthcare, Inc. · 2001 · Recalled
- 2 generations backK121108 Dopplex AbilityHuntleigh Healthcare · 2013
- 1 generation backK143152 TM-ABI systemLd Technology, LLC · 2015
- This deviceK172655 Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK201046 Automated ankle brachial pressure index measuring device, MESI…Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK191266 VitalScan ANSMedeia, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002186 | Vascular Assist | Huntleigh Healthcare, Inc. | 2001 | 1 |
| −2 | K121108 | Dopplex Ability | Huntleigh Healthcare | 2013 | — |
| −1 | K143152 | TM-ABI system | Ld Technology, LLC | 2015 | — |
| 0 (this device) | K172655 | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018 | — |
| +1 | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020 | — |
| +1 | K191266 | VitalScan ANS | Medeia, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143152 | TM-ABI systemSummary page 4…Hydraulic, Pneumatic, or Photoelectric Plethysmographs PRO CODE: JOM SUBSTANTIALLY EQUIVALENT TO: K143152 TM-ABI System Cleared July 22, 2015 DESCRIPTION of the DEVICE: The ABPI MD system, is an automated… | 2015 |
What descends from it? (2)
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 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K201046 (Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143152.
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. 2018, 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 ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). The ABPI MD 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 (134 words)
The ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
The ABPI MD 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 application of conipression therapy.
The ABPI MD system can be used on patients with unilateral lower limb amputation.
The ABPI MD system is intended to be used to spot-check patients.
The ABPI MD systein provides information regarding patient risk.
The physician has the responsibility of making proper judgements based on this information.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172655: Automated ankle brachial pressure index measuring device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172655
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