510(k) · Cleared

Cleared

BIB Stent Placement Catheter

K160889510(k) TraditionalCleared May 20, 201650-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

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

Cleared on May 20, 2016 as substantially equivalent to K050857 (NuMED, Inc., 2005) after a 50-day review. Its family tree reaches back 2 generations to 1993.

Decided: May 20, 2016
Review: 50 days
Class: Class II
Product code: NVM
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K931009 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK931009 Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc. · 1993 · Recalled
1 generation backK050857 Bib Pta Balloon CatheterNuMED, Inc. · 2005 · Recalled
This deviceK160889 BIB Stent Placement CatheterNuMED, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K931009	Tyshak Peripheral Balloon Dilation Catheter	NuMED, Inc.	1993	1
−1	K050857	Bib Pta Balloon Catheter	NuMED, Inc.	2005	1
0 (this device)	K160889	BIB Stent Placement Catheter	NuMED, Inc.	2016	—

FIG. 1 — Lineage of K160889, 1993–2016Source: 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 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

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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
*	K050857	Bib Pta Balloon Catheter Summary page 4 …Classification Name: Catheter, Percutaneous Class II, 21 CFR 870.1250 – Product Code NVM Predicate BIB PTA Catheter, Model 420– K050857 Device Device The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP Description Stent / Covere…	NuMED, Inc.	2005	1
†	P150028	CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP…	NuMED, Inc.	2016	—

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 23 years and passes through 1 company; a new generation was cleared every 11.6 years on median.
2 of the 2 ancestors have a recall of any class.

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. 2016, this device’s year, is highlighted.

FDA decisions per year · NVM

1in 2022

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	1
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	0	—	1
2015	0	—	0
2016	2	—	0
2017	0	—	0
2018	0	—	3
2019	0	—	5
2020	0	—	2
2021	1	—	2
2022	1	—	4
2023	0	—	1
2024	0	—	4
2025	0	—	2
2026	0	—	—

What is it indicated for?

Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K160889 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160889: BIB Stent Placement Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160889

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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