Cleared Traditional

INTERMEDICS/GRASEBY DYNAMICS MS 36 (K843331) - FDA 510(k) Clearance

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

K843331 · Intermedics, Inc. · General Hospital
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Nov 1984
Decision
80d
Days
Class 2
Risk

K843331 is an FDA 510(k) clearance for the INTERMEDICS/GRASEBY DYNAMICS MS 36. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on November 15, 1984 after a review of 80 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 Intermedics, Inc. devices

Submission Details

510(k) Number K843331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date November 15, 1984
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 240
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K843331.
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
K844091 · Abbott Laboratories · Jan 1985
ABBOTT LIFECARE 500 INFUSER
K844768 · Abbott Laboratories · Jan 1985
I.V. PUMP ADMINISTRATION SET
K843949 · Travenol Laboratories, S.A. · Nov 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · Intermedics, Inc. · Oct 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · Sherwood Medical Co. · Aug 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · Abbott Laboratories · Jun 1984