510(k) · Cleared
ClearedAutomated ankle brachial pressure index measuring device, MESI mTABLET system
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 Dec 11, 2020 as substantially equivalent to K172655 (Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd., 2018) after a 234-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Dec 11, 2020
- Review
- 234 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002186 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK002186 Vascular AssistHuntleigh Healthcare, Inc. · 2001 · Recalled
- 3 generations backK121108 Dopplex AbilityHuntleigh Healthcare · 2013
- 2 generations backK143152 TM-ABI systemLd Technology, LLC · 2015
- 1 generation backK172655 Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2018
- This deviceK201046 Automated ankle brachial pressure index measuring device, MESI…Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002186 | Vascular Assist | Huntleigh Healthcare, Inc. | 2001 | 1 |
| −3 | K121108 | Dopplex Ability | Huntleigh Healthcare | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020 | — |
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 |
|---|---|---|---|
| * | K172655 | Automated ankle brachial pressure index measuring deviceSummary page 4…FICATION Class II PRO CODE: JOM SUMMARY of SUBSTANTIALLY EQUIVALENCE TO: ABPI MD, K172655 The MESI mTABLET ABI has the same indication for use and intended use as the ABPI MD predicate device, also manufactured by MESI… | 2018 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K172655.
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. 2020, 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 MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (ABI) and pulse 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…
Read the full statement (126 words)
The MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (ABI) and pulse 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 compression therapy.
MESI mTABLET ABI can be used on patients with unilateral lower limb amputation.
The MESI mTABLET ABI is intended to be used to spot-check patients.
The MESI mTABLET 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/K201046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201046: Automated ankle brachial pressure index measuring device, MESI mTABLET system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201046
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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