Cleared Traditional

K832410 - GRASEBY DYNAMICS MS302 SYRINGE DRIVER

K832410 is an FDA 510(k) clearance for GRASEBY DYNAMICS MS302 SYRINGE DRIVER, 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 53-day FDA review.

K832410 · Intermedics, Inc. · General Hospital
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Sep 1983
Decision
53d
Days
Class 2
Risk

K832410 is an FDA 510(k) clearance for the GRASEBY DYNAMICS MS302 SYRINGE DRIVER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 53 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 - K832410

510(k) Number K832410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1983
Decision Date September 12, 1983
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 K832410.
SINGLE USE SYRINGE #103 PERSONAL MEDIC
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K832008 · Valleylab, Inc. · Aug 1983