Cleared Traditional

K193664 - SubQKath Catheter and Needle Set

K193664 is an FDA 510(k) clearance for SubQKath Catheter and Needle Set, manufactured by Hk Surgical. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K193664 · Hk Surgical · Anesthesiology device
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Sep 2020
Decision
253d
Days
Class 2
Risk

K193664 is an FDA 510(k) clearance for the SubQKath Catheter and Needle Set. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Hk Surgical (San Clemente, US). The FDA issued a Cleared decision on September 9, 2020 after a review of 253 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 Hk Surgical devices

FDA 510(k) Submission Details - K193664

510(k) Number K193664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2019
Decision Date September 09, 2020
Days to Decision 253 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
113d slower than avg
Panel avg: 140d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSO Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BSO Catheter, Conduction, Anesthetic

All 61
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K193664.
EDEN ControlCath
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K200624 · Epimed International, Inc. · Apr 2020
C-CAT Anaesthesia Catheter kit
K191470 · Cimpax Aps · Oct 2019
Medline Reinforced Epidural Catheter
K181782 · Medline Industries, Inc. · Mar 2019