Cleared Traditional

K964435 - PRIMARY IV SET

K964435 is an FDA 510(k) clearance for PRIMARY IV SET, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K964435 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
148d
Days
Class 2
Risk

K964435 is an FDA 510(k) clearance for the PRIMARY IV SET. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 148 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 Icu Medical, Inc. devices

FDA 510(k) Submission Details - K964435

510(k) Number K964435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date April 02, 1997
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 53
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K964435.
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393 · Elcam Medical Acal · Sep 2003
MANIFOLD WITH EXTENSION SET
K982368 · Interpore Cross Intl. · Jul 1998
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083 · Ohmeda Medical · Jan 1998
TRI-FLOW THREE WAY STOPCOCK
K961982 · North, Inc. · Feb 1997
STOPCOCK MANIFOLD GANGS
K962581 · Baxter Healthcare Corp · Aug 1996
STOPCOCK & LUER LOCK PLUG
K954970 · Medex, Inc. · Apr 1996