510(k) Report

510(k) · Decided

Recalled · Class II · 2025

Bib Pta Balloon Catheter

K050857510(k) TraditionalDecided Jul 28, 2005114-day reviewClass II21 CFR 870.1250Recalls 1

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

NuMED, Inc. · NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

Cleared on Jul 28, 2005 as substantially equivalent to K931009 (NuMED, Inc., 1993) after a 114-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.

Decided
Jul 28, 2005
Review
114 days
Class
Class II
Product code
NVM
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K931009 (1993). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant clearedK931009 · Tyshak Peripheral Balloon Dilation Catheter · NuMED, Inc. · 1993 · recalled1990200020102020
Descendants, by generation 1 generation forward: 1 descendant K931009 · Tyshak Peripheral Balloon Dilation Catheter · NuMED, Inc. · 1993 · recalled0
  1. Root · 1 generation backK931009 Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc. · 1993 · Recalled
  2. This deviceK050857 Bib Pta Balloon CatheterNuMED, Inc. · 2005
  3. Descendant · cites it directly · 0 of its ownK160889 BIB Stent Placement CatheterNuMED, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K160889BIB Stent Placement CatheterNuMED, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931009Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc.19931
0 (this device)K050857Bib Pta Balloon CatheterNuMED, Inc.2005—
+1K160889BIB Stent Placement CatheterNuMED, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K050857, 1993–2016Source: 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 NVM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K931009Tyshak Peripheral Balloon Dilation Catheter
Summary page 1
…BIB PTA Balloon Catheter Provisions Classification Name: Percutaneous Transluminal Angioplasty Catheter Name of Tyshak PTA Balloon Catheter (K931009) Predicate Z-Med PTA Balloon Catheter (K931009) Device Classification Class II Performance Performance Standard…
NuMED, Inc.19931

Also cleared against K931009: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160889BIB Stent Placement CatheterNuMED, Inc.20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 21, 2025Class IIZ-1754-2025Mixed-up of materials/componentsBalloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K160889 (NuMED, Inc., 2016) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K931009.

How does its category compare?

All NVM devices

NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NVM

1in 2022

2016: 22021: 12022: 1
2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVM

Too few NVM 510(k)s in any year since 2007 to give a median.

Recalls per year · NVM

No recall names NVM since 2007.

Adverse event reports per year · NVM

2in 2025

2009: 12013: 12014: 12018: 32019: 52020: 22021: 22022: 42023: 12024: 42025: 2
2007high 5 (2019) · low 0 (2007)2025

MAUDE reports naming product code NVM, 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
20070—00
20080—00
20090—01
20100—00
20110—00
20120—00
20130—01
20140—01
20150—00
20162—00
20170—00
20180—03
20190—05
20200—02
20211—02
20221—04
20230—01
20240—04
20250—02
20260—0—

What is it indicated for?

This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.

Indications for use as stated in the FDA summary.

Also cleared against K931009

3 other devices cite the same predicate.

  • K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2004
  • K013601Numed Mullins Pta CatheterNuMED, Inc. · 2002
  • K991977Tyshak, Model 102 and Z-Med, Model 302NuMED, Inc. · 2000

More from NuMED, Inc.

57 FDA decisions under this applicant name. See the company

  • P150028/S007CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP…NuMED, Inc. · 2026
  • K213915BIB Stent Placement CatheterNuMED, Inc. · 2022
  • P150028/S006G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted StentNuMED, Inc. · 2021
  • P150028/S005NuDEL Delivery SystemNuMED, Inc. · 2021
  • K211910Z-6 Atrioseptostomy CatheterNuMED, Inc. · 2021

Recent decisions in NVM

The NVM category page

  • K213915BIB Stent Placement CatheterNuMED, Inc. · 2022
  • K211134BIB Stent Placement CatheterNuMED, Inc. · 2021
  • K161451BIB Stent Placement CatheterNuMED, Inc. · 2016
  • K160889BIB Stent Placement CatheterNuMED, Inc. · 2016

https://510kreport.com/device/K050857 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050857: Bib Pta Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050857

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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