510(k) Report

510(k) · Cleared

Cleared

Ultraverse RX Pta Balloon Dilatation Catheter

K131199510(k) TraditionalCleared May 30, 201334-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

Bard Peripheral Vascular, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on May 30, 2013 as substantially equivalent to K121856 (C.R. Bard, Inc., 2012) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 2004. 11 later devices descend from it.

Decided
May 30, 2013
Review
34 days
Class
Class II
Product code
LIT
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K042537 (2004). 6 ancestors in all, the oldest K012913 (2001). 11 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2010: 1 other ancestor2001: 1 other ancestor2016: 3 descendants cleared2018: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2026: 1 descendant cleared2022: 1 descendant cleared2020: 2 descendants clearedK042537 · Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx · Invatec Innovative Technologies · 2004K072947 · Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters · ClearStream Technologies, Ltd. · 2008K100490 · Litepac, Model 682 · ClearStream Technologies, Ltd. · 2010200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K100490 · Litepac, Model 682 · ClearStream Technologies, Ltd. · 2010K072947 · Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters · ClearStream Technologies, Ltd. · 2008K042537 · Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx · Invatec Innovative Technologies · 20040
  1. Root · 3 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
  2. 2 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
  3. 1 generation backK100490 Litepac, Model 682ClearStream Technologies, Ltd. · 2010
  4. This deviceK131199 Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013
  5. Descendant · cites it directly · 4 of its ownK150865 Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation · 2015
  6. Descendant · cites it directly · 3 of its ownK180921 Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018
  7. Descendant · 2 generations on · 1 of its ownK152873 Crosstella RX Balloon Dilatation CatheterKANEKA Corporation · 2016
  8. Descendant · 2 generations on · 0 of its ownK252295 RyureiTerumo Corporation · 2026
  9. Descendant · 2 generations on · 0 of its ownK211349 Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2022

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2015: 12016: 32017: 22018: 12020: 22022: 12026: 1
2015high 3 (2016) · low 0 (2019)2026

Most influential descendants

Showing 5 of 11 · See all
  • K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation · 2015 · cites it directly4descendants
  • K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018 · cites it directly3descendants
  • K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation · 2016 · 2 generations on1descendant
  • K252295RyureiTerumo Corporation · 2026 · 2 generations on0descendants
  • K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K042537Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model…Invatec Innovative Technologies2004—
−2K072947Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersClearStream Technologies, Ltd.2008—
−1K100490Litepac, Model 682ClearStream Technologies, Ltd.2010—
0 (this device)K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.2013—
+1K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation2015—
+1K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.2018—
+2K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation2016—
+2K252295RyureiTerumo Corporation2026—
+2K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
201010
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201630
201720
201810
202020
202210
202610
FIG. 1 — Lineage of K131199, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K121856Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension
Summary page 1
…ssification: Class 11 Classification Panel: Cardiovascular Predicate Device: * Ultraverse 014/018 PTA Balloon Dilatation Catheter (K121856, cleared July 11, 2012) * Clearstreamn LitePAC RX PTA Catheter (K100490, cleared March 16, 2010) Bard P…
C.R. Bard, Inc.2012—
*K100490Litepac, Model 682
Summary page 1
…ar Predicate Device: * Ultraverse 014/018 PTA Balloon Dilatation Catheter (K121856, cleared July 11, 2012) * Clearstreamn LitePAC RX PTA Catheter (K100490, cleared March 16, 2010) Bard Peripheral Vascular, Inc. =L…
ClearStream Technologies, Ltd.2010—

Also cleared against K121856: 1 other device →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154
K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183
K171290Vela RX PTA Balloon Dilatation CatheterCuratia Medical20170
K160013Crosperio OTWKANEKA Corporation20160
K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160

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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K150865 (KANEKA Corporation, 2015) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K121856.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007: 62008: 82009: 72010: 132011: 102012: 192013: 142014: 122015: 192016: 112017: 92018: 62019: 42020: 92021: 42022: 82023: 62024: 62025: 32026 (partial year): 4
2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007: 64 days median2008: 53 days median2009: 29 days median2010: 78 days median2011: 82 days median2012: 29 days median2013: 79 days median2014: 90 days median2015: 112 days median2016: 116 days median2017: 57 days median2018: 118 days median2019: 40 days median2020: 125 days median2021: 61 days median2022: 122 days median2023: 167 days median2024: 43 days median2025: 90 days median2026 (partial year): 205 days median
2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2009: 22010: 12013: 2, 2 Class I2014: 32016: 12018: 22019: 32021: 12024: 22025: 1
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

2007: 5772008: 5132009: 6232010: 8092011: 8572012: 1,2772013: 1,2422014: 1,1782015: 1,2792016: 1,5292017: 2,0812018: 2,1882019: 2,4052020: 2,4432021: 2,4922022: 2,1552023: 1,8072024: 1,9132025: 2,073
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076640577
20088530513
20097292623
201013781809
201110820857
2012192901,277
201314792 (2)1,242
2014129031,178
20151911201,279
20161111611,529
201795702,081
2018611822,188
201944032,405
2020912502,443
202146112,492
2022812202,155
2023616701,807
202464321,913
202539012,073
202642050—

What is it indicated for?

Ultraverse® RX PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries. This catheter is not for use in coronary arteries.

Indications for use as stated in the FDA summary.

Also cleared against K121856

1 other device cites the same predicate.

  • K192318Ultraverse 014 and 018 PTA Balloon Dilatation CathetersBard Peripheral Vascular, Inc. · 2019

More from Bard Peripheral Vascular, Inc.

174 FDA decisions under this applicant name. See the company

  • P250050/S001Liverty™ TIPS Stent GraftBard Peripheral Vascular, Inc. · 2026
  • P250050Liverty™ TIPS Stent GraftBard Peripheral Vascular, Inc. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • P130029/S015Fluency™ Plus Endovascular Stent GraftBard Peripheral Vascular, Inc. · 2026
  • P070014/S069LifeStent™ 5F Vascular Stent SystemsBard Peripheral Vascular, Inc. · 2026

Recent decisions in LIT

The LIT category page

  • K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026
  • K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026
  • K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026
  • K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025

https://510kreport.com/device/K131199 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131199: Ultraverse RX Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131199

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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