Cleared Traditional

Health Line CT CVC (K192533) - FDA 510(k) Clearance

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

K192533 · Health Line International Corporation · General Hospital
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Dec 2019
Decision
85d
Days
Class 2
Risk

K192533 is an FDA 510(k) clearance for the Health Line CT CVC. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on December 10, 2019 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health Line International Corporation devices

Submission Details

510(k) Number K192533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2019
Decision Date December 10, 2019
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 138
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K192533.
Introcan Safety 2 IV Catheter 18-24 gauge
K192676 · B.Braun Medical, Inc. · Apr 2020
Health Line CT Midline Catheter
K200263 · Health Line International Corporation · Mar 2020
BD Cathena (TM) Safety IV Catheter
K192493 · Becton Dickinson Infusion Therapy Systems, Inc. · Jan 2020
BD Acute Central Line
K190855 · Bard Access Systems, Inc. (Bard Has Joined Bd) · Nov 2019
Supercath 5
K190001 · Togo Medikit Co., Ltd. · Sep 2019
AccuCath Ace Intravascular Catheter
K191232 · C.R. Bard, Inc. · Sep 2019