510(k) · Cleared

Cleared

Highlander™ 014 PTA Balloon Dilatation Catheter

K223177510(k) TraditionalCleared Jan 20, 2023101-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

C.R. Bard, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Jan 20, 2023 as substantially equivalent to K192318 (Bard Peripheral Vascular, Inc., 2019) after a 101-day review. Its family tree reaches back 4 generations to 2001.

Decided: Jan 20, 2023
Review: 101 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K012913 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK012913 Bard Utaverse Small Vessel Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2001
3 generations backK093965 Ultraverse 014 and 018 Balloon Dilatation CathetersC.R. Bard, Inc. · 2010
2 generations backK121856 Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionC.R. Bard, Inc. · 2012
1 generation backK192318 Ultraverse 014 and 018 PTA Balloon Dilatation CathetersBard Peripheral Vascular, Inc. · 2019
This deviceK223177 Highlander™ 014 PTA Balloon Dilatation CatheterC.R. Bard, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K012913	Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter	C.R. Bard, Inc.	2001	—
−3	K093965	Ultraverse 014 and 018 Balloon Dilatation Catheters	C.R. Bard, Inc.	2010	—
−2	K121856	Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension	C.R. Bard, Inc.	2012	—
−1	K192318	Ultraverse 014 and 018 PTA Balloon Dilatation Catheters	Bard Peripheral Vascular, Inc.	2019	—
0 (this device)	K223177	Highlander™ 014 PTA Balloon Dilatation Catheter	C.R. Bard, Inc.	2023	—

FIG. 1 — Lineage of K223177, 2001–2023Source: 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? (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
*	K192318	Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Summary page 4 …LIT Regulatory Class : Class II Regulation Number : 21 CFR 870.1250 Predicate Device: 510(k) Number : K192318 Name of Device : Ultraverse™ 014 and 018 PTA Balloon Dilatation Catheters Common or Usual Name: Cat…	Bard Peripheral Vascular, Inc.	2019	—
†	K072283	Dorado Pta Balloon Dilatation Catheter	Bard Peripheral Vascular, Inc.	2007	15

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 22 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
None of the 4 ancestors has a recall.

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. 2023, 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 Highlander™ 014 PTA Balloon Dilatation Catheter is indicated for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal, infra-popliteal and renal arteries. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K223177 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223177: Highlander™ 014 PTA Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223177

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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