Cleared Traditional

K854397 - HEMOSTATIC SIDEARM

K854397 is the FDA 510(k) clearance for HEMOSTATIC SIDEARM by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K854397 · Target Therapeutics · Cardiovascular device
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Jan 1986
Decision
69d
Days
Class 2
Risk

K854397 is an FDA 510(k) clearance for the HEMOSTATIC SIDEARM. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Target Therapeutics (Los Angeles, US). The FDA issued a Cleared decision on January 8, 1986 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - the FDA cardiovascular device oversight 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 Target Therapeutics devices

Submission Details

510(k) Number K854397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1985
Decision Date January 08, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 69
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K854397.
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
K863661 · Medical Components, Inc. · Sep 1986
DISPOSABLE STOPCOCK
K861783 · Utah Medical Products, Inc. · Jul 1986
DISPOSABLE MANIFOLD
K854960 · Utah Medical Products, Inc. · Feb 1986
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950 · American Bentley · Dec 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · Advanced Cardiovascular Systems, Inc. · Dec 1985
PRESSURE SENSING SYRINGE 65000
K853586 · Dlp, Inc. · Nov 1985