Cleared Traditional

3000 INFUSION PUMP (K912193) - FDA 510(k) Clearance

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

K912193 · Graseby Medical , Ltd. · General Hospital
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Feb 1992
Decision
273d
Days
Class 2
Risk

K912193 is an FDA 510(k) clearance for the 3000 INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Graseby Medical , Ltd. (Watford, Herts., GB). The FDA issued a Cleared decision on February 14, 1992 after a review of 273 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Graseby Medical , Ltd. devices

Submission Details

510(k) Number K912193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1991
Decision Date February 14, 1992
Days to Decision 273 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 129d · This submission: 273d
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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K912193.
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · Abbott Laboratories · Mar 1992
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992
FLO-GARD(R) 6301
K915523 · Baxter Healthcare Corp · Feb 1992
PROVIDER APM INFUSION PUMP
K914349 · Abbott Laboratories · Dec 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · Abbott Laboratories · Oct 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · Abbott Laboratories · Oct 1991