Cleared Traditional

K921378 - IMED MODEL PC-4 VOLUMETRIC INFUSION PUM...

K921378 is the FDA 510(k) clearance for IMED MODEL PC-4 VOLUMETRIC INFUSION PUM... by Imed Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K921378 · Imed Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
78d
Days
Class 2
Risk

K921378 is an FDA 510(k) clearance for the IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Imed Corp. (San Diego, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 78 days - a notably fast clearance 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: 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

Submission Details

510(k) Number K921378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date June 09, 1992
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 306
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K921378.
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · Abbott Laboratories · Apr 1993
IVAC SYRINGE PUMP - 740 SERIES
K923981 · Y · Jan 1993
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · Abbott Laboratories · Dec 1992
DURAFUSE INFUSION PUMP
K920773 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1992
FLO-GARD 8000 HALF-SET
K915499 · Baxter Healthcare Corp · Mar 1992
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · Abbott Laboratories · Mar 1992