510(k) Report

510(k) · Cleared

Cleared

Bolton Pta Catheter

K021996510(k) TraditionalCleared Aug 23, 200266-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

Bolton Medical, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Aug 23, 2002 as substantially equivalent to K972512 (Boston Scientific Scimed, Inc., 1998) and 5 other predicates after a 66-day review. Its family tree reaches back 3 generations to 1992.

Decided
Aug 23, 2002
Review
66 days
Class
Class II
Product code
LIT
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K920547 (1992). 19 ancestors in all, the oldest K904984 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1998: 2 other ancestors1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1993: 5 other ancestors1992: 1 other ancestor1991: 2 other ancestorsK920547 · Ultra-Thin · Boston Scientific Corp · 1992K965183 · Vantage Peripheral Dilatation Catheter · Guidant Corp. · 1997K983830 · Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter · Mallinckroot, Inc. · 199919901992199419961998200020022004
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 10 other ancestors3 generations back: 1 other ancestor K983830 · Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter · Mallinckroot, Inc. · 1999K965183 · Vantage Peripheral Dilatation Catheter · Guidant Corp. · 1997K920547 · Ultra-Thin · Boston Scientific Corp · 19920
  1. Root · 3 generations backK920547 Ultra-ThinBoston Scientific Corp · 1992
  2. 2 generations backK965183 Vantage Peripheral Dilatation CatheterGuidant Corp. · 1997
  3. 1 generation backK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
  4. This deviceK021996 Bolton Pta CatheterBolton Medical, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K920547Ultra-ThinBoston Scientific Corp1992—
−2K965183Vantage Peripheral Dilatation CatheterGuidant Corp.1997—
−1K983830Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc.1999—
0 (this device)K021996Bolton Pta CatheterBolton Medical, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199210
199350
199410
199510
199610
199820
200020
200110
FIG. 1 — Lineage of K021996, 1992–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (6)

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
*K972512Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel
Summary page 1
…e: Percutaneous Catheter (21 CFR 870.1250) 3. Predicate o r legally marketed devices that are substantially equivalent: SmashTMPTA Catheter, Schneider (USA) Inc. (K972512) NuMED Ghost II PTA Catheter, NuMED, Inc. (K003972) PTA Balloon Catheter, Cook Incorporated (KO01087) ' R X VIATRA…
Boston Scientific Scimed, Inc.1998—
*K003972Numed Ghost II Pta Catheters
Summary page 1
…o r legally marketed devices that are substantially equivalent: SmashTMPTA Catheter, Schneider (USA) Inc. (K972512) NuMED Ghost II PTA Catheter, NuMED, Inc. (K003972) PTA Balloon Catheter, Cook Incorporated (KO01087) ' R X VIATRAC 14 Peripheral Dilalation Catheter, Guidant Corporation…
NuMED, Inc.2001—
*K001087Pta Balloon CatheterCook, Inc.2000—
*K000101RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp.2000—
*K983830Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter
Summary page 1
…ok Incorporated (KO01087) ' R X VIATRAC 14 Peripheral Dilalation Catheter, Guidant Corporation (KO00101) Finch and Copperhead PTA Catheters, Mallinckrodt, Inc. (K983830) ' Qpti-plast@ Centurion 5.5 PTA Catheter, C.R. Bard, Inc. (K973012) 4. Description of the device: The Bolton PTA Catheter…
Mallinckroot, Inc.1999—
*K973013Opti-Plast (Centurion) 5.5F Angioplasty Catheter
Our reading of the summary gave K973012, FDA’s number for MDC Safe Step Safety Blood Collection Needle System (MDC Research, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Opti-plast Centurion 5.5 PTA Catheter”.
Vas-Cath, Inc.1998—

Also cleared against K972512: 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 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • None of the 19 ancestors has a recall.
  • 1 other device also cites its predicate K972512.

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.

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?

The Bolton PTA Catheter is indicated for percutaneous transluminal angioplasty of narrowed or obstructed peripheral arteries such as the iliac, femoral, iliofemoral, renal, popliteal, tibial, tibioperoneal, infrapopliteal, peroneal, and profunda vessels and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is not intended for use in the coronary arteries.

Indications for use as stated in the FDA summary.

Also cleared against K972512

1 other device cites the same predicate.

  • K992320Megabello Percutaneous Transluminal Angioplasty (Pta) CatheterBoston Scientific Corp · 2000

More from Bolton Medical, Inc.

81 FDA decisions under this applicant name. See the company

  • P200045/S024RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc. · 2026
  • P190015/S030TREO® Abdominal Stent-Graft SystemBolton Medical, Inc. · 2026
  • P190015/S024TREO® Abdominal Stent-Graft SystemBolton Medical, Inc. · 2026
  • P200045/S017RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc. · 2026
  • P190015/S026TREO® Abdominal Stent-Graft SystemBolton Medical, 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/K021996 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021996: Bolton Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021996

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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