510(k) · Cleared
ClearedThe CVC WAND Safety Introducer with Valved Peelable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Scientific, LLC · DYB Introducer, Catheter
Cleared on Sep 18, 2018 as substantially equivalent to K131148 (Access Scientific, LLC, 2013) after a 29-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Sep 18, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K932323 (1993). 16 ancestors in all, the oldest K840455 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 7 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 6 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 5 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 4 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 3 generations backK101150 Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 2 generations backK111138 The Picc Wand (R) Peelable Safety IntroducerAccess Scientific, Inc. · 2011
- 1 generation backK131148 The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC · 2013
- This deviceK182243 The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −7 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −6 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −5 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −4 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −3 | K101150 | Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −2 | K111138 | The Picc Wand (R) Peelable Safety Introducer | Access Scientific, Inc. | 2011 | — |
| −1 | K131148 | The CVC Wand Safety Introducer with Valved Peelable Sheath | Access Scientific, LLC | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K131148 | The CVC Wand Safety Introducer with Valved Peelable SheathSummary page 4…y Introducer with Valved Peelable Sheath is substantially equivalent to the following Access Scientific device, which is cleared for commercial distribution under 510(k) K131148: Trade Name: The CVC WAND™ Safety Introducer with Valved Peelable Sheath === Pa… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 16 ancestors have a recall of any class.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 CVC WAND Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182243: The CVC WAND Safety Introducer with Valved Peelable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182243
Report an extraction error
Are you the manufacturer?
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