510(k) · Cleared
ClearedThe Power Wand Safety Introducer with an Extended Dwell Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Scientific, Inc. · DYB Introducer, Catheter
Cleared on Mar 22, 2011 as substantially equivalent to K081697 (Access Scientific, Inc., 2008) and 3 other predicates after a 306-day review. Its family tree reaches back 5 generations to 1993. 25 later devices descend from it.
- Decided
- Mar 22, 2011
- Review
- 306 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K932323 (1993). 15 ancestors in all, the oldest K801941 (1980). 25 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 4 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 3 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 2 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 1 generation backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- This deviceK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- Descendant · cites it directly · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 5 of its ownK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK162377 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · cites it directly19descendants
- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 2 generations on12descendants
- K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 3 generations on5descendants
- K150407BioFlo Midline CatheterNavilyst Medical, Inc. · 2015 · 3 generations on5descendants
- K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −4 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −3 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −2 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −1 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| 0 (this device) | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| +1 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| +2 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| +3 | K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +3 | K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015 | — |
| +4 | K162377 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K081697 | The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Summary page 1…ion in the United States: SThe WANDTM MicroAccess Safety Introducer manufactured by Access Scientific and cleared for commercial distribution under 5 10(k) (K081 697) >The P1CC WANDTM Peclable Safety Introducer manufactured by Access Scientific. Inc. and cleared for comnmercial d… | 2008 |
| * | K093022 | The Picc Wand Peelable Safety IntroducerSummary page 1…10(k) (K081 697) >The P1CC WANDTM Peclable Safety Introducer manufactured by Access Scientific. Inc. and cleared for comnmercial distribution under 510(k) K093022 rThe Introcan Safety' IV Catheter manufactured by B3. Braun Medical. Inc. and cleared for commerci… | 2010 |
| * | K020785 | Introcan Safety IV CatheterSummary page 2…(k) K093022 rThe Introcan Safety' IV Catheter manufactured by B3. Braun Medical. Inc. and cleared for commercial distribution under 510(k) K020785 >The RD OnueCatlTM manufactured by B~ecton Dickinson Infusion Therapy Systems, Inc. and cleared for commercial distr… | 2002 |
| * | K042862 | BD Onecath | 2004 |
What descends from it? (25)
See all 252 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 18 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K121073 (C.R. Bard, Inc., 2012) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K081697.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Power WAND Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101422: The Power Wand Safety Introducer with an Extended Dwell Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101422
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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