Cleared Traditional

K864296 - S.C.T. MULTI PORT

K864296 is the FDA 510(k) clearance for S.C.T. MULTI PORT by Salt Creek Medical Technologies. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K864296 · Salt Creek Medical Technologies · General Hospital
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Mar 1987
Decision
122d
Days
Class 2
Risk

K864296 is an FDA 510(k) clearance for the S.C.T. MULTI PORT, INJECTION SITE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Salt Creek Medical Technologies (Canfield, US). The FDA issued a Cleared decision on March 2, 1987 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Salt Creek Medical Technologies devices

Submission Details

510(k) Number K864296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date March 02, 1987
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 465
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K864296.
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET
K870581 · Strato Medical Corp. · Apr 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE
K870582 · Strato Medical Corp. · Apr 1987
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
K870940 · Travenol Laboratories, S.A. · Mar 1987
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164 · Y · Dec 1986
SECONDARY SET LOCK
K864338 · Travenol Laboratories, S.A. · Nov 1986
LUER LOCK ADAPTER/NUT
K862653 · Mallinckrodt Critical Care · Jul 1986