510(k) · Cleared
ClearedSecureloc; Advancintroducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialized Health Products, Inc. · DYB Introducer, Catheter
Cleared on Feb 18, 2005 as substantially equivalent to K030135 (B.Braun Medical, Inc., 2003) after a 44-day review. Its family tree reaches back 4 generations to 1980. 5 later devices descend from it.
- Decided
- Feb 18, 2005
- Review
- 44 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K801941 (1980). 8 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 3 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 2 generations backK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 1 generation backK030135 Safety Introducer NeedleB.Braun Medical, Inc. · 2003
- This deviceK050023 Secureloc; AdvancintroducerSpecialized Health Products, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK142445 Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK162769 Pinpoint GT Introducer NeedleC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK140513 Merit Safety Introducer NeedleMerit Medical Systems, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K142445Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc. · 2015 · cites it directly1descendant
- K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007 · cites it directly1descendant
- K180725Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018 · 2 generations on0descendants
- K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. · 2016 · 2 generations on0descendants
- K140513Merit Safety Introducer NeedleMerit Medical Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −3 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −2 | K021094 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 1 |
| −1 | K030135 | Safety Introducer Needle | B.Braun Medical, Inc. | 2003 | — |
| 0 (this device) | K050023 | Secureloc; Advancintroducer | Specialized Health Products, Inc. | 2005 | — |
| +1 | K142445 | Pinpoint GT Safety Introducer Needle | C.R. Bard, Inc. | 2015 | — |
| +1 | K070449 | Lumiloc (TM) Safety Introducer Needle | Specialized Health Products International, Inc. | 2007 | — |
| +2 | K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | 2018 | — |
| +2 | K162769 | Pinpoint GT Introducer Needle | C.R. Bard, Inc. | 2016 | — |
| +1 | K140513 | Merit Safety Introducer Needle | Merit Medical Systems, Inc. | 2014 | — |
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 |
|---|---|---|
| 2007 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030135 | Safety Introducer NeedleSummary page 1…ospital Class: 1I Procode: DYI3 Regulation Number: 21 CER 870.1340 STATEMENT OF SUBSTANTIAL EQUI VALENCE (Predicate Device References): 1. Safety Introducer Needles (K030135,), B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown, PA 18109. 2. MajestikFmAngiographic Introducer Needles (pre-a… | 2003 |
| * | — | Majestik Angiographic Introducer Needles Named without a submission number |
What descends from it? (5)
3 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 25 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K142445 (C.R. Bard, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K030135.
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?
SecureLocTM Safety Introducer Needles are intended to be used for those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLocTM Safety Introducer Needles are intended to be used as integral safety-needle devices for those patients requiring percutaneous procedures utilizing an introducer needle for…
Read the full statement (225 words)
SecureLocTM Safety Introducer Needles are intended to be used for those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures.
The SecureLocTM Safety Introducer Needles are intended to be used as integral safety-needle devices for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures.
The SecureLocTM Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and reduces the risk of accidental needlestick injuries by locking a safety guard over the needle tip. The safety guard can be activated over stylettes, obturators, and guidewires.
Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical end-users.
May be used in any appropriate patient population.
AdvanclntroducerTM Introducer Needles are intended to be used with those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures.
Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical end-users.
May be used in any appropriate patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050023: Secureloc; Advancintroducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050023
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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