Cleared Traditional

K991936 - 3.0 ML RESERVOIR

K991936 is the FDA 510(k) clearance for 3.0 ML RESERVOIR by Medtronic Minimed. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K991936 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
223d
Days
Class 2
Risk

K991936 is an FDA 510(k) clearance for the 3.0 ML RESERVOIR, MODEL 103/193. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 223 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 K991936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1999
Decision Date January 18, 2000
Days to Decision 223 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 129d · This submission: 223d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K991936.
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