510(k) Report

510(k) · Cleared

Recalled · 2004

Braun Percutaneous Introducer Set

K961745510(k) TraditionalCleared Sep 17, 1996134-day reviewClass II21 CFR 870.1340Recalls 1

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

B.Braun Medical, Inc. · DYB Introducer, Catheter

Cleared on Sep 17, 1996 as substantially equivalent to K810460 (Burron Medical Products, Inc., 1981) and 8 other predicates after a 134-day review. Its family tree reaches back 1 generation to 1977. 1 of the 10 devices in its family, counting itself, has a Class I recall. It has been recalled once.

Decided
Sep 17, 1996
Review
134 days
Class
Class II
Product code
DYB
Recalls
1
Predicates
9

Its longest line of descent runs back 1 generation to K770561 (1977). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1993: 1 other ancestor1989: 3 other ancestors1985: 1 other ancestor1981: 1 other ancestor1978: 1 other ancestor, 1 with a Class I recall11977: 1 other ancestorK770561 · Catheter,Percutaneous Introduc. & Sheath · Usci, Div. C.R. Bard, Inc. · 197719751980198519901995
Other ancestors, by generation 1 generation back: 8 other ancestors, 1 with a Class I recall1 K770561 · Catheter,Percutaneous Introduc. & Sheath · Usci, Div. C.R. Bard, Inc. · 19770
  1. Root · 1 generation backK770561 Catheter,Percutaneous Introduc. & SheathUsci, Div. C.R. Bard, Inc. · 1977
  2. This deviceK961745 Braun Percutaneous Introducer SetB.Braun Medical, Inc. · 1996

Class I recalls in this family

  • K780126 Dilator, Vessel & Introducer, Sheathdirect predicate · 1978
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K770561Catheter,Percutaneous Introduc. & SheathUsci, Div. C.R. Bard, Inc.1977—
0 (this device)K961745Braun Percutaneous Introducer SetB.Braun Medical, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
197811
198110
198510
198930
199310
FIG. 1 — Lineage of K961745, 1977–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

1 device in this family has a Class I recall. 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 DYB device

  1. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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
*K810460Burron Percutaneous Inducer Set
Summary page 1
…6 Common or Usual Name: Braun Percutaneous introducer Set Device Classification Name: Catheter Introducers & vessel dilators K| 74sS &‘P,,ms Substantial Equivilance: K810460 Burron Percutaneous Introducer Set K894446 Angeion Hemostasis Introducer Set K894343 andfor KB84494 Venous Introducer B. Braun M…
Burron Medical Products, Inc.1981—
*K894446Angeion Hemostasis Valve Introducer
Summary page 1
…introducer Set Device Classification Name: Catheter Introducers & vessel dilators K| 74sS &‘P,,ms Substantial Equivilance: K810460 Burron Percutaneous Introducer Set K894446 Angeion Hemostasis Introducer Set K894343 andfor KB84494 Venous Introducer B. Braun Medical, Inc. B. Braun Medical, inc. Daig K…
Angeion Corp.19891
*K894343Daig Percutaneous Catheter Intro. & Removable Hemo
Summary page 1
…Catheter Introducers & vessel dilators K| 74sS &‘P,,ms Substantial Equivilance: K810460 Burron Percutaneous Introducer Set K894446 Angeion Hemostasis Introducer Set K894343 andfor KB84494 Venous Introducer B. Braun Medical, Inc. B. Braun Medical, inc. Daig K771982 andfor K770561 “888" Percutaneous C…
Daig Corp.1989—
*K884494Daig Obturator, Catheter IntroducerDaig Corp.19891
*K771982888 Arterial/Venous Catheter Introducer
Summary page 1
…urron Percutaneous Introducer Set K894446 Angeion Hemostasis Introducer Set K894343 andfor KB84494 Venous Introducer B. Braun Medical, Inc. B. Braun Medical, inc. Daig K771982 andfor K770561 “888" Percutaneous Catheter Introducer uscl K780126 PCI Kit Argon K850820 Arterial/Venous Percutaneous Catheter In…
Usci, Div. C.R. Bard, Inc.1977—
*K770561Catheter,Percutaneous Introduc. & Sheath
Summary page 1
…ous Introducer Set K894446 Angeion Hemostasis Introducer Set K894343 andfor KB84494 Venous Introducer B. Braun Medical, Inc. B. Braun Medical, inc. Daig K771982 andfor K770561 “888" Percutaneous Catheter Introducer uscl K780126 PCI Kit Argon K850820 Arterial/Venous Percutaneous Catheter Introducer Univer…
Usci, Div. C.R. Bard, Inc.1977—
*K780126Dilator, Vessel & Introducer, Sheath
Summary page 1
…ucer Set K894343 andfor KB84494 Venous Introducer B. Braun Medical, Inc. B. Braun Medical, inc. Daig K771982 andfor K770561 “888" Percutaneous Catheter Introducer uscl K780126 PCI Kit Argon K850820 Arterial/Venous Percutaneous Catheter Introducer Universal Medical Instrument{UMI) K932733 Valveless{Portle…
Argon Medical Corp.1978Class I
*K850820Percutaneous Catheter Introducer W/Cath-Seal & Sid
Summary page 1
…r KB84494 Venous Introducer B. Braun Medical, Inc. B. Braun Medical, inc. Daig K771982 andfor K770561 “888" Percutaneous Catheter Introducer uscl K780126 PCI Kit Argon K850820 Arterial/Venous Percutaneous Catheter Introducer Universal Medical Instrument{UMI) K932733 Valveless{Portless Sheath Introducer C…
Universal Medical Instrument Corp.1985—
*K932733Cordis Catheter Sheath Introducer
Summary page 1
…dfor K770561 “888" Percutaneous Catheter Introducer uscl K780126 PCI Kit Argon K850820 Arterial/Venous Percutaneous Catheter Introducer Universal Medical Instrument{UMI) K932733 Valveless{Portless Sheath Introducer Cordis Device Description: Braun Percutaneous Introducer Kits consist of an introducer she…
Cordis Corp.1993—

Also cleared against K810460: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 16, 2004Not classifiedZ-1133-04OtherCatheter separated from the hub.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K780126Dilator, Vessel & Introducer, SheathArgon Medical Corp. · 1978 · Direct predicate · ◆ in the 1978 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K810460.

How does its category compare?

All DYB devices

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

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

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

Also cleared against K810460

1 other device cites the same predicate.

  • K021094Introcan Safety IV CatheterB.Braun Medical, Inc. · 20021 recall

More from B.Braun Medical, Inc.

151 FDA decisions under this applicant name. See the company

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254111Irrigation/Urology SetsB.Braun Medical, Inc. · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026
  • K243392Infusomat® Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2025
  • K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc. · 2024

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K961745 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961745: Braun Percutaneous Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961745

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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