Cleared Traditional

K950153 - VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES

K950153 is an FDA 510(k) clearance for VENTED/NONVENTED GEMINI ADMINISTRATION ..., manufactured by Imed Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K950153 · Imed Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
219d
Days
Class 2
Risk

K950153 is an FDA 510(k) clearance for the VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(T.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Imed Corp. (San Diego, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 219 days - an extended review 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: 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 Imed Corp. devices

FDA 510(k) Submission Details - K950153

510(k) Number K950153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date August 24, 1995
Days to Decision 219 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 129d · This submission: 219d
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 644
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K950153.
IVAC BALL VALCE ADMIN. SETS
K953225 · Y · Sep 1995
INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
K952160 · Medex, Inc. · Sep 1995
PLASTIC BLUNT CANNULA
K952976 · Marquette Medical, Inc. · Sep 1995
FIXED FLOW RATE GRAVITY ADMINISTRATION SETS
K952760 · I-Flow Corp. · Aug 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074 · Baxter Healthcare Corp · Jul 1995
ADMINISTRATION SETS WITH BALL FLOAT
K951922 · Imed Corp. · Jul 1995