510(k) · Cleared

Cleared

Burron Percutaneous Inducer Set

K810460510(k) TraditionalCleared Mar 11, 198119-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

Burron Medical Products, Inc. · DQY Catheter, Percutaneous

Cleared on Mar 11, 1981 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.

Decided: Mar 11, 1981
Review: 19 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 0

28 later devices descend from it, 2 citing it directly.

This deviceK810460 Burron Percutaneous Inducer SetBurron Medical Products, Inc. · 1981
Descendant · cites it directly · 26 of its ownK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
Descendant · 2 generations on · 15 of its ownK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled
Descendant · 3 generations on · 9 of its ownK163358 Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017
Descendant · 3 generations on · 8 of its ownK182870 Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · Recalled
Descendant · 2 generations on · 7 of its ownK030135 Safety Introducer NeedleB.Braun Medical, Inc. · 2003

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1996high 4 (2020) · low 0 (1997)2026

Most influential descendants

Showing 5 of 28 · See all

K021094Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · cites it directly26descendants
K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG · 2011 · 2 generations on15descendants
K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017 · 3 generations on9descendants
K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · 3 generations on8descendants
K030135Safety Introducer NeedleB.Braun Medical, Inc. · 2003 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K810460	Burron Percutaneous Inducer Set	Burron Medical Products, Inc.	1981	—
+1	K021094	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	1
+2	K111236	Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4…	B.Braun Melsungen AG	2011	1
+3	K163358	Introcan Safety 3 Closed IV Catheter	B.Braun Melsungen AG	2017	—
+3	K182870	Introcan Safety 3 Closed IV Catheter	B.Braun Medical, Inc.	2019	1
+2	K030135	Safety Introducer Needle	B.Braun Medical, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2002	1	0
2003	1	0
2005	1	0
2007	1	0
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2016	1	0
2017	2	0
2018	1	0
2019	1	0
2020	4	0
2021	1	0
2022	3	0
2023	1	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K810460, 1981–2026Source: 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 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?

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

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K021094	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	26
K961745	Braun Percutaneous Introducer Set	B.Braun Medical, Inc.	1996	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, K021094 (B.Braun Medical, Inc., 2002) has gone furthest, with 26 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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)	—

https://510kreport.com/device/K810460 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810460: Burron Percutaneous Inducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810460

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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