Cleared Traditional

EXTERNAL INFUSION PUMP (K830151) - FDA 510(k) Clearance

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

K830151 · Intermedics, Inc. · General Hospital
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Feb 1983
Decision
32d
Days
Class 2
Risk

K830151 is an FDA 510(k) clearance for the EXTERNAL INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983 after a review of 32 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 K830151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1983
Decision Date February 18, 1983
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 K830151.
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
K830809 · Intermedics, Inc. · Apr 1983
SYRINGE DRIVER MS-16
K830423 · Intermedics, Inc. · Mar 1983
HARVARD APPARATUS INTERMITTENT INFUSION
K830102 · C.R. Bard, Inc. · Feb 1983
HARVARD APPARATUS FAMILY OF FLUID INFUS
K830177 · C.R. Bard, Inc. · Feb 1983
VOLUMETRIC PUMP ADMIN. SETS
K830017 · Travenol Laboratories, S.A. · Jan 1983
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB
K823063 · Travenol Laboratories, S.A. · Nov 1982