Cleared Traditional

K870913 - INJECTION SITE #014456-120

K870913 is an FDA 510(k) clearance for INJECTION SITE #014456-120, manufactured by Clinical Connections, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K870913 · Clinical Connections, Inc. · General Hospital
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Mar 1987
Decision
11d
Days
Class 2
Risk

K870913 is an FDA 510(k) clearance for the INJECTION SITE #014456-120. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Clinical Connections, Inc. (Orrville, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 11 days - a notably fast clearance cycle.

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: 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 Clinical Connections, Inc. devices

FDA 510(k) Submission Details - K870913

510(k) Number K870913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1987
Decision Date March 17, 1987
Days to Decision 11 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
118d faster than avg
Panel avg: 129d · This submission: 11d
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 514
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K870913.
CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
K871732 · Churchill Corp. · Jun 1987
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