Cleared Traditional

K844851 - MINIMED EXTERNAL INFUSION PUMP FOR DIAG...

K844851 is the FDA 510(k) clearance for MINIMED EXTERNAL INFUSION PUMP FOR DIAG... by Pacesetter Systems. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K844851 · Pacesetter Systems · General Hospital
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Jan 1985
Decision
40d
Days
Class 2
Risk

K844851 is an FDA 510(k) clearance for the MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on January 22, 1985 after a review of 40 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 Pacesetter Systems devices

Submission Details

510(k) Number K844851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1984
Decision Date January 22, 1985
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 443
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K844851.
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
K844091 · Abbott Laboratories · Jan 1985
ABBOTT LIFECARE 500 INFUSER
K844768 · Abbott Laboratories · Jan 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · Pacesetter Systems · Jan 1985
I.V. PUMP ADMINISTRATION SET
K843949 · Travenol Laboratories, S.A. · Nov 1984
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · Intermedics, Inc. · Nov 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · Intermedics, Inc. · Oct 1984