510(k) · Cleared

Cleared

The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006

K081697510(k) TraditionalCleared Dec 4, 2008170-day reviewClass II21 CFR 870.1340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Access Scientific, Inc. · DYB Introducer, Catheter

Cleared on Dec 4, 2008 as substantially equivalent to K840455 (Arrow Intl., Inc., 1984) and 2 other predicates after a 170-day review. Its family tree reaches back 3 generations to 1993. 27 later devices descend from it.

Decided: Dec 4, 2008
Review: 170 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K932323 (1993). 6 ancestors in all, the oldest K840455 (1984). 27 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
2 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
1 generation backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
This deviceK081697 The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005…Access Scientific, Inc. · 2008
Descendant · cites it directly · 25 of its ownK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
Descendant · 2 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
Descendant · 3 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
Descendant · 4 generations on · 5 of its ownK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
Descendant · 4 generations on · 5 of its ownK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2011high 4 (2016) · low 0 (2018)2026

Most influential descendants

Showing 5 of 27 · See all

K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · cites it directly25descendants
K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 2 generations on19descendants
K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 3 generations on12descendants
K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 4 generations on5descendants
K150407BioFlo Midline CatheterNavilyst Medical, Inc. · 2015 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K932323	Percutaneous Introducer	Medamicus, Inc.	1993	—
−2	K990705	Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator…	Medamicus, Inc.	1999	1
−1	K071574	Stiffer Coaxial Micro-Introducer Kit	Enpath Medical, Inc.	2007	2
0 (this device)	K081697	The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006	Access Scientific, Inc.	2008	—
+1	K101422	The Power Wand Safety Introducer with an Extended Dwell Catheter	Access Scientific, Inc.	2011	—
+2	K121073	Powerglide Midline Catheter	C.R. Bard, Inc.	2012	1
+3	K133856	Powerglide Midline Catheter	C.R. Bard, Inc.	2014	1
+4	K153280	PowerGlide Pro Midline Catheter	C.R. Bard, Inc.	2016	—
+4	K150407	BioFlo Midline Catheter	Navilyst Medical, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1998	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	3	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

FIG. 1 — Lineage of K081697, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K840455	Emergency Infusion Device Summary page 1 …ices, which are cleared for commercial distribution in the United States: Arrow International Emergency Infusion Device distributed under cleared 510(k) Number K840455 a BD Introsyte Precision Introducer distributed under cleared 5 10(k) Number K020834 (Beckton Dickinson infusion Therapy Sy…	Arrow Intl., Inc.	1984	—
*	K020834	BD Introsyte Precision Introducer; BD Introsyte-N Precision Introducer; BD Introsyte… Summary page 1 …ternational Emergency Infusion Device distributed under cleared 510(k) Number K840455 a BD Introsyte Precision Introducer distributed under cleared 5 10(k) Number K020834 (Beckton Dickinson infusion Therapy Systems, Inc.) * Stiffer Coaxial Micro-Introducer Set distributed under cleared 510(k)…	Becton Dickinson Infusion Therapy Systems, Inc.	2002	—
*	K071574	Stiffer Coaxial Micro-Introducer Kit Summary page 1 …leared 5 10(k) Number K020834 (Beckton Dickinson infusion Therapy Systems, Inc.) * Stiffer Coaxial Micro-Introducer Set distributed under cleared 510(k) Number K071574 (Enpath Medical, Inc.) Access Scientific, Inc. Original…	Enpath Medical, Inc.	2007	2

Also cleared against K840455: 1 other device →

What descends from it? (27)

See all 27

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101422	The Power Wand Safety Introducer with an Extended Dwell Catheter	Access Scientific, Inc.	2011	25
K111426	Euclid (TM) Tier 1-GW Access System	Houston Medical Robotics	2012	0

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 15 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
3 of the 6 ancestors have a recall of any class.
Of its descendants, K101422 (Access Scientific, Inc., 2011) has gone furthest, with 25 descendants of its own.
1 other device also cites its predicate K840455.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)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 WAND TM MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081697 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081697: The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081697

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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