510(k) · Cleared

Cleared

PTA 14 Balloon Dilatation Catheter OTW

K142954510(k) TraditionalCleared May 28, 2015230-day reviewClass II21 CFR 870.1250

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

Texasmedical Technologies, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on May 28, 2015 as substantially equivalent to K042624 (Invatec Innovative Technologies, S.R.L., 2005) and 2 other predicates after a 230-day review. Its family tree reaches back 1 generation to 2005.

Decided: May 28, 2015
Review: 230 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K042624 (2005). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK042624 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2005 · Recalled
This deviceK142954 PTA 14 Balloon Dilatation Catheter OTWTexasmedical Technologies, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042624	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2005	1
0 (this device)	K142954	PTA 14 Balloon Dilatation Catheter OTW	Texasmedical Technologies, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0

FIG. 1 — Lineage of K142954, 2005–2015Source: 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 LIT? 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 LIT device

#1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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? (3)

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
*	K042624	Amphirion Deep 0.014 Otw Pta Balloon Catheter Summary page 4 …Regulation Number: 21 CFR 870.1250 Product Code: LIT Device Class: II Primary Predicate 510(k) Number: K042624 Secondary Predicate 510k Number: K050073, K052791 4 – Device Description The PTA 14 Balloon Dilatation…	Invatec Innovative Technologies, S.R.L.	2005	1
*	K050073	Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter Summary page 4 …LIT Device Class: II Primary Predicate 510(k) Number: K042624 Secondary Predicate 510k Number: K050073, K052791 4 – Device Description The PTA 14 Balloon Dilatation Catheter OTW is a 0.014” Over-The-Wire (OTW) PTA Balloon Dilatati…	Invatec Innovative Technologies, S.R.L.	2005	1
*	K052791	Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter Summary page 4 …LIT Device Class: II Primary Predicate 510(k) Number: K042624 Secondary Predicate 510k Number: K050073, K052791 4 – Device Description The PTA 14 Balloon Dilatation Catheter OTW is a 0.014” Over-The-Wire (OTW) PTA Balloon Dilatation Cathet…	Invatec Innovative Technologies, S.R.L.	2005	1

Also cleared against K042624: 4 other devices →

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?

3 of the 3 ancestors have a recall of any class.
4 other devices also cite its predicate K042624.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LIT

1in 2025

2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

What is it indicated for?

The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142954 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142954: PTA 14 Balloon Dilatation Catheter OTW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142954

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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