510(k) · Cleared

Recalled · Class II · 2018

Sheath Adapter, Model SA-09847

K021723510(k) TraditionalCleared Aug 8, 200276-day reviewClass II21 CFR 870.1340Recalls 1

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

Arrow Intl., Inc. · DYB Introducer, Catheter

Cleared on Aug 8, 2002 as substantially equivalent to K780532 (Arrow Intl., Inc., 1978) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1978. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled once.

Decided: Aug 8, 2002
Review: 76 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K780532 (1978). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK780532 Percutaneous Sheath Introducer KitArrow Intl., Inc. · 1978 · Recalled (Class I)
This deviceK021723 Sheath Adapter, Model SA-09847Arrow Intl., Inc. · 2002

Class I recalls in this family

K780532 Percutaneous Sheath Introducer Kitdirect predicate · 1978

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K780532	Percutaneous Sheath Introducer Kit	Arrow Intl., Inc.	1978	Class I
0 (this device)	K021723	Sheath Adapter, Model SA-09847	Arrow Intl., Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

FIG. 1 — Lineage of K021723, 1978–2002Source: 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.

1 device in this family has a Class I recall. 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? (2)

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
*	K780532	Percutaneous Sheath Introducer Kit Summary page 1 …Sheath Adapter Device classification name: Catheter Introducer Legally marketed devices to which Arrow Percutaneous Sheath Introducer (K780532) the device is substantially equivalent: Thomas Medical Products Tuohy-Borst Adapter (K904608) Description of the device:…	Arrow Intl., Inc.	1978	Class I
*	K904608	Percutaneous Introducer Tray Summary page 1 …marketed devices to which Arrow Percutaneous Sheath Introducer (K780532) the device is substantially equivalent: Thomas Medical Products Tuohy-Borst Adapter (K904608) Description of the device: The proposed device is an accessory to Arrow’s existing…	Thomas Medical Products, Inc.	1990	—

Also cleared against K780532: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 11, 2018	Class II	Z-2029-2018	Under Investigation by firm	Product sterility may be compromised due to unsealed packaging.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K780532Percutaneous Sheath Introducer KitArrow Intl., Inc. · 1978 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
2 other devices also cite its predicate K780532.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Arrow Sheath Adapter is utilized in conjunction with one-piece Percutaneous Sheath Introducer to permit venous access and catheter introduction into the central circulation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021723 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021723: Sheath Adapter, Model SA-09847.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021723

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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