510(k) · Cleared

Cleared

Focus Balloon Dilatation Catheter

K944016510(k) TraditionalCleared Dec 20, 1994126-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

Cardiovascular Dynamics, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Dec 20, 1994 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided: Dec 20, 1994
Review: 126 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 0

12 later devices descend from it, 3 citing it directly.

This deviceK944016 Focus Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1994
Descendant · cites it directly · 9 of its ownK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
Descendant · 2 generations on · 6 of its ownK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
Descendant · 2 generations on · 5 of its ownK051254 Peripheral Cutting BalloonBoston Scientific Ivt · 2005
Descendant · 2 generations on · 5 of its ownK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
Descendant · 3 generations on · 4 of its ownK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 12 · See all

K022061Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002 · cites it directly9descendants
K040155Peripheral Cutting BalloonBoston Scientific Corp · 2004 · 2 generations on6descendants
K051254Peripheral Cutting BalloonBoston Scientific Ivt · 2005 · 2 generations on5descendants
K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004 · 2 generations on5descendants
K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation · 2005 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944016	Focus Balloon Dilatation Catheter	Cardiovascular Dynamics, Inc.	1994	—
+1	K022061	Cvsi Peripheral Balloon Catheter; Cvsi Inflater	Cryo Vascular Systems, Inc.	2002	—
+2	K040155	Peripheral Cutting Balloon	Boston Scientific Corp	2004	—
+2	K051254	Peripheral Cutting Balloon	Boston Scientific Ivt	2005	—
+2	K041993	2 CM Peripheral Cutting Baloon	Boston Scientific Ivt	2004	—
+3	K052038	Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System	Boston Scientific Corporation	2005	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
2002	1	0
2003	1	0
2004	2	0
2005	2	0
2006	1	0
2007	1	0
2015	1	0
2024	1	0

FIG. 1 — Lineage of K944016, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K022061	Cvsi Peripheral Balloon Catheter; Cvsi Inflater	Cryo Vascular Systems, Inc.	2002	9
K971577	Focus-PV Balloon Dilatation Catheter	Cardiovascular Dynamics, Inc.	1997	0
K963688	Focus PV Balloon Dilatation Catheter	Cardiovascular Dynamics, Inc.	1997	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?

Of its descendants, K022061 (Cryo Vascular Systems, Inc., 2002) has gone furthest, with 9 descendants of its own.

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

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

https://510kreport.com/device/K944016 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944016: Focus Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944016

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026