Cleared Traditional

K843331 - INTERMEDICS/GRASEBY DYNAMICS MS 36

K843331 is an FDA 510(k) clearance for INTERMEDICS/GRASEBY DYNAMICS MS 36, manufactured by Intermedics, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 80-day FDA review.

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

FDA 510(k) Submission Details - K843331

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.

FRN Device Classification - Class 2, Special Controls

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 463
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K843331.
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · Pacesetter Systems · Jan 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
K844851 · Pacesetter Systems · Jan 1985
I.V. PUMP ADMINISTRATION SET
K843949 · Travenol Laboratories, S.A. · Nov 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · Intermedics, Inc. · Oct 1984
ENTERAL FEEDING PUMP 14-800 SERIES
K843168 · Biosearch Medical Products, Inc. · Oct 1984
MODULAR VOLUMETRIC INFUSION PUMP SYS
K843274 · American Edwards Laboratories · Oct 1984