Cleared Traditional

IVAC PC ANIFUSER (K915063) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915063 · Y · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
208d
Days
Class 2
Risk

K915063 is an FDA 510(k) clearance for the IVAC PC ANIFUSER. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on June 3, 1992 after a review of 208 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 K915063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date June 03, 1992
Days to Decision 208 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 129d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEA Pump, Infusion, Pca
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MEA Pump, Infusion, Pca

Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K915063.
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp · Sep 2000
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K921994 · C.R. Bard, Inc. · Aug 1992
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502 · C.R. Bard, Inc. · Dec 1991