Cleared Traditional

K851360 - IMED GRAVISET INTRAVASCULAR ADMIN. SET

K851360 is an FDA 510(k) clearance for IMED GRAVISET INTRAVASCULAR ADMIN. SET, manufactured by Imed Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K851360 · Imed Corp. · General Hospital
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May 1985
Decision
34d
Days
Class 2
Risk

K851360 is an FDA 510(k) clearance for the IMED GRAVISET INTRAVASCULAR ADMIN. SET. 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 May 8, 1985 after a review of 34 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

FDA 510(k) Submission Details - K851360

510(k) Number K851360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1985
Decision Date May 08, 1985
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 526
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K851360.
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K852060 · Cardiac Pacemakers, Inc. · Jun 1985
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
K852073 · Hospal Medical Corp. · Jun 1985
MODEL 2000 INDULIN INFUSION PUMP
K851564 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1985
IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP
K851447 · Y · May 1985
QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU
K851017 · Quest Medical, Inc. · May 1985
IMED 440 INFUSION PUMP & ADMINISTRATION SET
K850653 · Imed Corp. · Apr 1985