Cleared Traditional

K895436 - MODIFIED MINIMED III INFUSION PUMP

K895436 is the FDA 510(k) clearance for MODIFIED MINIMED III INFUSION PUMP by Medtronic Minimed. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K895436 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
289d
Days
Class 2
Risk

K895436 is an FDA 510(k) clearance for the MODIFIED MINIMED III INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 289 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 Medtronic Minimed devices

Submission Details

510(k) Number K895436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date May 24, 1990
Days to Decision 289 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
160d slower than avg
Panel avg: 129d · This submission: 289d
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 437
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K895436.
TFV-2300 INFUSION PUMP
K890736 · Nihon Kohden America, Inc. · Jul 1990
LIFECARE MICRO PUMP (INFUSION PUMP)
K893769 · Abbott Laboratories · Jun 1990
PANCRETEC I.V. MODEL 5000 INFUSER
K895867 · Abbott Laboratories · Jun 1990
LOCKBOX
K900888 · Pharmacia Deltec, Inc. · May 1990
FLO-GARD 6300 BLOOD PUMPING INDICATION
K900699 · Baxter Healthcare Corp · Apr 1990
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
K900204 · 3M Company · Apr 1990