Cleared Traditional

K844843 - IVAC DRUG ADMINISTRATION DEVICE

K844843 is the FDA 510(k) clearance for IVAC DRUG ADMINISTRATION DEVICE by Y. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K844843 · Y · General Hospital
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Apr 1985
Decision
117d
Days
Class 2
Risk

K844843 is an FDA 510(k) clearance for the IVAC DRUG ADMINISTRATION DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on April 9, 1985 after a review of 117 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 Y devices

Submission Details

510(k) Number K844843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1984
Decision Date April 09, 1985
Days to Decision 117 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
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 470
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K844843.
CHURCHILL VENTED IV SET
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CORRECT FLO
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MICRO VOLUME DOUBLE LINE EXTENSION SET
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CRITIKON I.V. ADMINISTRAION SET
K850507 · Critikon Company, LLC · Mar 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937 · Y · Jan 1985