Cleared Traditional

K230603 - Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) (FDA 510(k) Clearance)

Also includes:
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)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230603 · Teleflex Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
180d
Days
Class 2
Risk

K230603 is an FDA 510(k) clearance for the Arrow Non-Stimulating SnapLock Adapter (K-05520-005C). Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 30, 2023 after a review of 180 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflex Medical devices

Submission Details

510(k) Number K230603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date August 30, 2023
Days to Decision 180 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 139d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.