Cleared Traditional

K812823 - IMED MODEL 970 & 975 VOL. INFUSION PUMP

K812823 is the FDA 510(k) clearance for IMED MODEL 970 & 975 VOL. 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 19-day FDA review.

K812823 · Imed Corp. · General Hospital
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Oct 1981
Decision
19d
Days
Class 2
Risk

K812823 is an FDA 510(k) clearance for the IMED MODEL 970 & 975 VOL. INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Imed Corp. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1981 after a review of 19 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 K812823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1981
Decision Date October 27, 1981
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 K812823.
FLO-GARD 8000 INFUSION PUMP SYSTEM
K813403 · Travenol Laboratories, S.A. · Dec 1981
PERSONAL MEDICATION INFUSER
K810850 · Pacesetter Systems · Nov 1981
PORTABLE LIDOCAINE INFUSION PUMP
K812917 · Cardiac Pacemakers, Inc. · Nov 1981
3M INFUSION SYSTEM
K812442 · 3M Company · Sep 1981
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · Terumo Medical Corp. · Sep 1981
VOLUMETRIC INFUSION PUMP
K812021 · American Edwards Laboratories · Jul 1981