Cleared Traditional

K951922 - ADMINISTRATION SETS WITH BALL FLOAT

K951922 is an FDA 510(k) clearance for ADMINISTRATION SETS WITH BALL FLOAT, 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 86-day FDA review.

K951922 · Imed Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
86d
Days
Class 2
Risk

K951922 is an FDA 510(k) clearance for the ADMINISTRATION SETS WITH BALL FLOAT. 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 July 19, 1995 after a review of 86 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 Imed Corp. devices

FDA 510(k) Submission Details - K951922

510(k) Number K951922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date July 19, 1995
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 K951922.
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES
K950153 · Imed Corp. · Aug 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
FILTERED EXTENSION SETS
K942988 · B. Braun of America, Inc. · Jul 1995
SMARTFLOW I ADMINISTRATION SET
K945298 · River Medical, Inc. · Jun 1995
E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS
K952053 · Becton Dickinson Vascular Access, Inc. · May 1995