Cleared Traditional

K901949 - IV SET

K901949 is an FDA 510(k) clearance for IV SET, manufactured by Jfv, 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.

K901949 · Jfv, Inc. · General Hospital
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Sep 1990
Decision
135d
Days
Class 2
Risk

K901949 is an FDA 510(k) clearance for the IV SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Jfv, Inc. (Spencer, US). The FDA issued a Cleared decision on September 12, 1990 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 Jfv, Inc. devices

FDA 510(k) Submission Details - K901949

510(k) Number K901949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date September 12, 1990
Days to Decision 135 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
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 835
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K901949.
KAWASUMI BLOOD ADMINISTRATION SET
K896894 · Kawasumi Laboratories Co., Ltd. · Sep 1990
KAWASUMI I.V. ADMINISTRATION SET
K896895 · Kawasumi Laboratories Co., Ltd. · Sep 1990
KAWASUMI SMALL VEIN INFUSION SET
K896896 · Kawasumi Laboratories Co., Ltd. · Sep 1990
WINGED INFUSION SET
K902166 · Therex Corp. · Aug 1990
EXEL HUBER INFUSION SET
K895770 · Exel Intl. · Jul 1990
IN-LINE VIAL CONNECTION SITE
K900909 · Baxter Healthcare Corp · May 1990