Cleared Traditional

K991936 - 3.0 ML RESERVOIR, MODEL 103/193

K991936 is an FDA 510(k) clearance for 3.0 ML RESERVOIR, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K991936

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.

FRN Device Classification - Class 2, Special Controls

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 590
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K991936.
HORIZON LIGHT
K994375 · B.Braun Medical, Inc. · Mar 2000
SOAKER CATHETER
K994374 · I-Flow Corp. · Mar 2000
SIMS PORTEX ANESTHESIA CATHETER
K994275 · Sims Portex, Inc. · Feb 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
K994039 · Abbott Laboratories · Dec 1999
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K993387 · Baxter Healthcare Corp · Nov 1999
IRRIGATION OR INFUSION PUMP K PUMP
K991203 · Kmi Kolster Methods, Inc. · Oct 1999