510(k) · Cleared

Cleared

Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)

K230603510(k) TraditionalCleared Aug 30, 2023180-day reviewClass II21 CFR 868.5120

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

Teleflex Medical · BSO Catheter, Conduction, Anesthetic

Cleared on Aug 30, 2023 as substantially equivalent to K103658 (Teleflex, Inc., 2012) after a 180-day review. Its family tree reaches back 2 generations to 1989. 2 of the 3 devices in its family, counting itself, have a Class I recall.

Decided: Aug 30, 2023
Review: 180 days
Class: Class II
Product code: BSO
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K884552 (1989). No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK884552 Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · Recalled (Class I)
1 generation backK103658 Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Recalled (Class I)
This deviceK230603 Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow…Teleflex Medical · 2023

Class I recalls in this family

K103658 Flextip Plus Closed Tip Epidural Catherterdirect predicate · 2012
K884552 Continuous Epidural Anesthesia Kit W/Poly Catheter2 generations back · 1989

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K884552	Continuous Epidural Anesthesia Kit W/Poly Catheter	Arrow Intl., Inc.	1989	Class I
−1	K103658	Flextip Plus Closed Tip Epidural Catherter	Teleflex, Inc.	2012	Class I
0 (this device)	K230603	Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating…	Teleflex Medical	2023	—

FIG. 1 — Lineage of K230603, 1989–2023Source: 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.

2 devices in this family have 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 BSO device

#1 K241410 EDEN ControlCathscore 9.4 · 3 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? (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	Applicant	Decided	Recalls
*	K103658	Flextip Plus Closed Tip Epidural Catherter Summary page 4 …er (with cable) TZ-05000-002 Arrow Stimulating SnapLock Adapter (with tab) Predicate Device The primary predicate device for this submission was cleared in K103658 on May 16, 2012. The reference predicate device for this submission was cleared in K1220247 on Aug 28, 2012. Device…	Teleflex, Inc.	2012	Class I
†	K122027	Arrow Flexblock Continuous Peripheral Nerve Block Catheter	Arrow International, Inc.	2012	Class I

Also cleared against K103658: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

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.

K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K884552Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 23.2 years on median.
2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
3 other devices also cite its predicate K103658.

How does its category compare?

All BSO devices

BSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · BSO

1in 2025

2007high 5 (2016) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSO

205in 2017

2007high 281 (2016) · low 109 (2011)2026

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

Recalls per year · BSO

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSO

139in 2025

2007high 779 (2019) · low 14 (2008)2025

MAUDE reports naming product code BSO, 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	2	—	0	18
2008	3	155	0	14
2009	1	—	1	71
2010	1	—	0	57
2011	4	109	0	31
2012	0	—	0	52
2013	1	—	0	73
2014	2	—	0	45
2015	1	—	0	43
2016	5	281	0	71
2017	3	205	0	38
2018	2	—	0	80
2019	2	—	0	779
2020	2	—	0	159
2021	0	—	0	146
2022	0	—	0	135
2023	2	—	0	79
2024	0	—	0	98
2025	1	—	0	139
2026	0	—	2 (1)	—

What is it indicated for?

SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Management Catheter IFU for complete catheter instructions for use. The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for…

Read the full statement (116 words)

The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.

The Arrow FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K230603 · printed Nov 5, 2026

Cite this page

510(k) Report. “K230603: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230603

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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