510(k) · Cleared
ClearedSafety Introducer Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · DYB Introducer, Catheter
Cleared on Jul 15, 2003 as substantially equivalent to K011085 (Medamicus, Inc., 2001) and 1 other predicate after a 182-day review. Its family tree reaches back 3 generations to 1980. 7 later devices descend from it.
- Decided
- Jul 15, 2003
- Review
- 182 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801941 (1980). 7 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 2 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 1 generation backK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- This deviceK030135 Safety Introducer NeedleB.Braun Medical, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK050023 Secureloc; AdvancintroducerSpecialized Health Products, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK142445 Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK162769 Pinpoint GT Introducer NeedleC.R. Bard, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc. · 2005 · cites it directly5descendants
- K142445Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc. · 2015 · 2 generations on1descendant
- K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007 · 2 generations on1descendant
- K180725Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018 · 3 generations on0descendants
- K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −2 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −1 | K021094 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 1 |
| 0 (this device) | K030135 | Safety Introducer Needle | B.Braun Medical, Inc. | 2003 | — |
| +1 | K050023 | Secureloc; Advancintroducer | Specialized Health Products, Inc. | 2005 | — |
| +2 | K142445 | Pinpoint GT Safety Introducer Needle | C.R. Bard, Inc. | 2015 | — |
| +2 | K070449 | Lumiloc (TM) Safety Introducer Needle | Specialized Health Products International, Inc. | 2007 | — |
| +3 | K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | 2018 | — |
| +3 | K162769 | Pinpoint GT Introducer Needle | C.R. Bard, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
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 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K050023 (Specialized Health Products, Inc., 2005) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K011085.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Safety Introducer Needle incorporates an active safety clip mechanism designed to minimize
inadvertent needlesticks when the needle is used to introduce a guidewire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030135 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030135: Safety Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030135
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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