Cleared Traditional

K874725 - SITE SOLUTION ADMINISTRATION SET

K874725 is an FDA 510(k) clearance for SITE SOLUTION ADMINISTRATION SET, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K874725 · Site Microsurgical Systems, Inc. · General Hospital
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Apr 1988
Decision
135d
Days
Class 2
Risk

K874725 is an FDA 510(k) clearance for the SITE SOLUTION ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on April 1, 1988 after a review of 135 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 Site Microsurgical Systems, Inc. devices

FDA 510(k) Submission Details - K874725

510(k) Number K874725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date April 01, 1988
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 129d · This submission: 135d
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 785
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K874725.
VENOVALVE(TM)
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K881052 · Baxter Healthcare Corp · May 1988
MARQUETTE MEDICAL, INC. IV EXTENSION SETS
K880928 · Marquette Medical, Inc. · Apr 1988
SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
K880482 · Baxter Healthcare Corp · Mar 1988
MODEL DMC-75 MINI-CATHETER SET
K874307 · Life-Tech Intl., Inc. · Jan 1988
IVAC(R) DUAL RATE ADAPTER - MODEL 70090
K874581 · Y · Jan 1988