510(k) Report

510(k) · Cleared

Cleared

Braun Hemostasis Introducers

K955820510(k) TraditionalCleared Mar 25, 199690-day reviewClass II21 CFR 870.1340

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 Mar 25, 1996 as substantially equivalent to K894446 (Angeion Corp., 1989) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided
Mar 25, 1996
Review
90 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K871153 (1987). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 2 other ancestors1989: 1 other ancestor2004: 1 descendant clearedK871153 · Catheter Introducer · Angeion Corp. · 1987 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K871153 · Catheter Introducer · Angeion Corp. · 1987 · recalled0
  1. Root · 1 generation backK871153 Catheter IntroducerAngeion Corp. · 1987 · Recalled
  2. This deviceK955820 Braun Hemostasis IntroducersB.Braun Medical, Inc. · 1996
  3. Descendant · cites it directly · 0 of its ownK033527 Intradyn Pediatric Hemostasis IntroducerB.Braun Medical, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K033527Intradyn Pediatric Hemostasis IntroducerB.Braun Medical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K871153Catheter IntroducerAngeion Corp.19872
0 (this device)K955820Braun Hemostasis IntroducersB.Braun Medical, Inc.1996—
+1K033527Intradyn Pediatric Hemostasis IntroducerB.Braun Medical, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199320
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K955820, 1987–2004Source: 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.

Planning a device in DYB? 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? (5)

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
*K894446Angeion Hemostasis Valve Introducer
Summary page 1
…r: 21 CFR Reference- 870.1340, Class |l Panei- 74 DYB Dilator; 21 CFR Reference- 870.1310, Class |, Panel- 74 DRE Substantial Equivilance: 510(k) # Product Manufacturer K894446 Angeion Hemostasis Valve Introducer Kit B. Braun Cardiovascular - MN K931743 Burron Cardiovascular Angestat B. Braun Cardiovascul…
Angeion Corp.19891
*K931743Burron Cardiovascular Angestat (TM)
Summary page 1
…ce- 870.1310, Class |, Panel- 74 DRE Substantial Equivilance: 510(k) # Product Manufacturer K894446 Angeion Hemostasis Valve Introducer Kit B. Braun Cardiovascular - MN K931743 Burron Cardiovascular Angestat B. Braun Cardiovascular - MN K871153 ANGETEAR Tear-away Introducer Kits B. Braun Cardiovascular -…
B.Braun Medical, Inc.1993—
*K871153Catheter Introducer
Summary page 1
…) # Product Manufacturer K894446 Angeion Hemostasis Valve Introducer Kit B. Braun Cardiovascular - MN K931743 Burron Cardiovascular Angestat B. Braun Cardiovascular - MN K871153 ANGETEAR Tear-away Introducer Kits B. Braun Cardiovascular - MN K930057 Fuoro-tip Hemostasis Introducer Set B. Braun Candiovascul…
Angeion Corp.19872
*K930057Angestat Fluoro-Tip Hemostasis Introducer Set
Summary page 1
…B. Braun Cardiovascular - MN K931743 Burron Cardiovascular Angestat B. Braun Cardiovascular - MN K871153 ANGETEAR Tear-away Introducer Kits B. Braun Cardiovascular - MN K930057 Fuoro-tip Hemostasis Introducer Set B. Braun Candiovascular - MN K945396 Fluoro-tip Hemostasis introducer Set 8. Braun Cardiovasc…
B.Braun Medical, Inc.1993—
*K945396Fluoro-Tip (R) Hemostasis Valve Introducer Set
Summary page 1
…raun Cardiovascular - MN K871153 ANGETEAR Tear-away Introducer Kits B. Braun Cardiovascular - MN K930057 Fuoro-tip Hemostasis Introducer Set B. Braun Candiovascular - MN K945396 Fluoro-tip Hemostasis introducer Set 8. Braun Cardiovascular - MN Device Description: - 16 Et 18 french versions of the Braun He…
B.Braun Medical, Inc.1995—

Also cleared against K894446: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033527Intradyn Pediatric Hemostasis IntroducerB.Braun Medical, Inc.20040

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?

  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K033527 (B.Braun Medical, Inc., 2004) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K894446.

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?

For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.

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 K894446

2 other devices cite the same predicate.

  • K033527Intradyn Pediatric Hemostasis IntroducerB.Braun Medical, Inc. · 2004
  • K961745Braun Percutaneous Introducer SetB.Braun Medical, Inc. · 19961 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/K955820 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955820: Braun Hemostasis Introducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955820

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