Cleared Traditional

K864296 - S.C.T. MULTI PORT, INJECTION SITE

K864296 is an FDA 510(k) clearance for S.C.T. MULTI PORT, manufactured by Salt Creek Medical Technologies. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K864296

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.

FPA Device Classification - Class 2, Special Controls

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 805
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
NORFOLK MEDICAL BUTTERFLY INFUSION SET
K870188 · Norfolk Medical Products, Inc. · Feb 1987
MANAN CONTRAST MEDIA ADMINISTRATION SET
K864405 · Manan Manufacturing Co., Inc. · Dec 1986
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164 · Y · Dec 1986