510(k) · Cleared

Cleared

Optimus 0.035 Inch Pta Balloon Dilatation Catheter

K072156510(k) TraditionalCleared Nov 9, 200798-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

Usci Ireland · DQY Catheter, Percutaneous

Cleared on Nov 9, 2007 as substantially equivalent to K032737 (Cordis Europa, N.V., 2003) after a 98-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Nov 9, 2007
Review: 98 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032737 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK032737 Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus…Cordis Europa, N.V. · 2003 · Recalled
This deviceK072156 Optimus 0.035 Inch Pta Balloon Dilatation CatheterUsci Ireland · 2007
Descendant · cites it directly · 0 of its ownK082646 Optimus 0.035 Pta Balloon Dilatation CatheterUsci Ireland · 2008

Most influential descendants

Showing 1 of 1 · See all

K082646Optimus 0.035 Pta Balloon Dilatation CatheterUsci Ireland · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032737	Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta…	Cordis Europa, N.V.	2003	1
0 (this device)	K072156	Optimus 0.035 Inch Pta Balloon Dilatation Catheter	Usci Ireland	2007	—
+1	K082646	Optimus 0.035 Pta Balloon Dilatation Catheter	Usci Ireland	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K072156, 2003–2008Source: 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 DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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
*	K032737	Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon… Summary page 1 …DQY) 3. Predicate Devices Device Name: Cordis OPTA PRO PTA Catheter 510(k) Clearance Number: K032737 This Premarket Notification (510(k) submission) aims to demonstrate "substantial equivalence (SE)" of the…	Cordis Europa, N.V.	2003	1

Also cleared against K032737: 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.

Number	Device	Applicant	Decided	Descendants
K082646	Optimus 0.035 Pta Balloon Dilatation Catheter	Usci Ireland	2008	0

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?

Its one ancestor has a recall.
Of its descendants, K082646 (Usci Ireland, 2008) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K032737.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072156 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072156: Optimus 0.035 Inch 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/K072156

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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