510(k) · Cleared
ClearedThe POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model
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 Jul 25, 2019 as substantially equivalent to K162322 (Access Scientific, LLC, 2016) after a 262-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Jul 25, 2019
- Review
- 262 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K932323 (1993). 20 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 6 generations between
- 3 generations backK121748 The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc. · 2012 · Recalled
- 2 generations backK131300 The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC · 2013 · Recalled
- 1 generation backK162322 the POWERWAND Safety Introducer with an Extended Dwell Catheter…Access Scientific, LLC · 2016
- This deviceK183066 The POWERWAND Safety Introducer with an Extended Dwell Catheter made…Access Scientific, LLC · 2019
Show all 10 generations
- Root · 10 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 9 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 8 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 7 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 6 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 5 generations backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- 4 generations backK111417 The Powerwand (R) Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · Recalled
- 3 generations backK121748 The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc. · 2012 · Recalled
- 2 generations backK131300 The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC · 2013 · Recalled
- 1 generation backK162322 the POWERWAND Safety Introducer with an Extended Dwell Catheter…Access Scientific, LLC · 2016
- This deviceK183066 The POWERWAND Safety Introducer with an Extended Dwell Catheter made…Access Scientific, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −9 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −8 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −7 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −6 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −5 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| −4 | K111417 | The Powerwand (R) Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | 1 |
| −3 | K121748 | The Powerwand Safety Introducer with and Extended Dwell | Access Scientific, Inc. | 2012 | 1 |
| −2 | K131300 | The Powerwand Safety Introducer with an Extended Dwell Catheter | Access Scientific, LLC | 2013 | 1 |
| −1 | K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | Access Scientific, LLC | 2016 | — |
| 0 (this device) | K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of… | Access Scientific, LLC | 2019 | — |
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 |
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 |
|---|---|---|---|
| * | K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelSummary page 4…TION The POWERWAND™ Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology has the following predicate device: • K162322 – POWERWAND™ Safety Introducer with an Extended Dwell Catheter, 3 Fr Model Pa… | 2016 |
| † | K131300 | The Powerwand Safety Introducer with an Extended Dwell Catheter | 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 26 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 20 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. 2019, 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 POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183066: The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183066
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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