510(k) · Cleared
ClearedAirguard Valved Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DYB Introducer, Catheter
Cleared on Aug 23, 2004 as substantially equivalent to K040150 (Medamicus, Inc., 2004) after a 25-day review. Its family tree reaches back 4 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 23, 2004
- Review
- 25 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932323 (1993). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 3 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 2 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 1 generation backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- This deviceK042036 Airguard Valved IntroducerC.R. Bard, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK131148 The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK182243 The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −3 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −2 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −1 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| 0 (this device) | K042036 | Airguard Valved Introducer | C.R. Bard, Inc. | 2004 | — |
| +1 | K131148 | The CVC Wand Safety Introducer with Valved Peelable Sheath | Access Scientific, LLC | 2013 | — |
| +2 | K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | Access Scientific, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K040150 | Modification to Medamicus Flowguard Peelable IntroducerSummary page 1…FR 870.1340 - Class II Classification Panel: Cardiovascular and Respiratory Devices Predicate Device: MedAnieus FlowGuardjlPeelableIntroducer, 510(k) K040150, FDA clearance date 02/18/2004 Summary of Change: The modification to the MedAmicus FlowGuardrMPeelable Introducer is a pas… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131148 | The CVC Wand Safety Introducer with Valved Peelable Sheath | 2013 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131148 (Access Scientific, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K040150.
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 AirGuard Valved Introducer is indicated for use in the percutaneous insertion of catheters in the venous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042036: Airguard Valved Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042036
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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