Cleared Traditional

K991979 - SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321

K991979 is an FDA 510(k) clearance for SOF-SET MICRO QR INFUSION SET, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K991979 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
81d
Days
Class 2
Risk

K991979 is an FDA 510(k) clearance for the SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Medtronic Minimed devices

FDA 510(k) Submission Details - K991979

510(k) Number K991979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1999
Decision Date September 03, 1999
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 779
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K991979.
ECOMED SCALP VEIN SET
K992145 · Greiner Meditech, Inc. · Oct 1999
BOLUS ACCESSORY SET
K992072 · I-Flow Corp. · Sep 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268 · The Kipp Group · Sep 1999
SAGE CONTRAST MANAGEMENT SYSTEM
K991112 · Sage Laboratories, Inc. · Sep 1999
MED-RX EXTENSION SETS
K990777 · Benlan, Inc. · Aug 1999
PARSET, MODEL A10001E
K992104 · Rd Medical Mfg., Inc. · Aug 1999