510(k) · Cleared

Cleared

TBL-ABI System

K173696510(k) SpecialCleared Dec 19, 201718-day reviewClass II21 CFR 870.2780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ld Technology, LLC · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Cleared on Dec 19, 2017 as substantially equivalent to K143152 (Ld Technology, LLC, 2015) after an 18-day review. Its family tree reaches back 3 generations to 2001.

Decided: Dec 19, 2017
Review: 18 days
Class: Class II
Product code: JOM
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K002186 (2001). No later device cites it as a predicate yet.

By dateBy generation

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 deviceK173696 TBL-ABI SystemLd Technology, LLC · 2017

View 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)	K173696	TBL-ABI System	Ld Technology, LLC	2017	—

FIG. 1 — Lineage of K173696, 2001–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K143152	TM-ABI system Summary page 4 …ss II Classification Name: Hydraulic, pneumatic, or photoelectric plethysmograph Classification Panel: Cardiology 3. Predicate legally marketed devices TM-ABI k143152 Applicant: LD TECHNOLOGY LLC. Product Code: JOM. 4. Device Description TBL-ABI System comprises:  3 Bluetooth blood pressu…	Ld Technology, LLC	2015	—

Also cleared against K143152: 1 other device →

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 16 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K143152.

How does its category compare?

All JOM devices

JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · JOM

2in 2022

2007high 2 (2007) · low 0 (2008)2026

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

2007high 1 (2007) · low 0 (2008)2025

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	MAUDE reports
2007	2	—	1
2008	0	—	0
2009	1	—	0
2010	2	—	0
2011	1	—	0
2012	1	—	0
2013	2	—	0
2014	0	—	0
2015	2	—	0
2016	0	—	0
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	2	—	0
2021	1	—	0
2022	2	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI 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 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…

Read the full statement (127 words)

The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

TBL-ABI 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 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.

TBL-ABI can be used on patients with unilateral lower limb amputation.

The TBL-ABI System is intended to be used to spot-check patients. The TBL-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/K173696 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173696: TBL-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/K173696

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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