Cleared Traditional

K870992 - IMED MODEL 965A VOLUMETRIC INFUSION PUMP

K870992 is the FDA 510(k) clearance for IMED MODEL 965A VOLUMETRIC INFUSION PUMP by Imed Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K870992 · Imed Corp. · General Hospital
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Jun 1987
Decision
85d
Days
Class 2
Risk

K870992 is an FDA 510(k) clearance for the IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP. 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 4, 1987 after a review of 85 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 K870992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1987
Decision Date June 04, 1987
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 K870992.
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
K870801 · Travenol Laboratories, S.A. · Sep 1987
RATE INFUSER SYSTEM
K872850 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K871728 · Abbott Laboratories · Jul 1987
HOMEPRO II VOLUMETRIC INFUSION PUMP
K870444 · American Edwards Laboratories · Apr 1987
MEDTRAC VP VOLUMETRIC INFUSION PUMP
K864997 · American Edwards Laboratories · Feb 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580
K864809 · Y · Feb 1987