Cleared Traditional

K992015 - FREEDOM INFUSION SYSTEM

K992015 is an FDA 510(k) clearance for FREEDOM INFUSION SYSTEM, manufactured by Novacon Corp.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K992015 · Novacon Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
87d
Days
Class 2
Risk

K992015 is an FDA 510(k) clearance for the FREEDOM INFUSION SYSTEM. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Novacon Corp. (Lake Elmo, US). The FDA issued a Cleared decision on September 10, 1999 after a review of 87 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 Novacon Corp. devices

FDA 510(k) Submission Details - K992015

510(k) Number K992015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1999
Decision Date September 10, 1999
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 48
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K992015.
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000
ALPHA INFUSION PUMP
K992551 · Advanced Infusion, Inc. · Oct 1999
INTRAOP CATHETER
K991543 · I-Flow Corp. · Oct 1999
MCKINLEY SP DISPOSABLE INFUSION PUMP
K990461 · Mckinley, Inc. · Jun 1999
AUTODOSE INFUSION SYSTEM
K990889 · Tandem Medical, Inc. · Jun 1999
NERVE BLOCK INFUSION KIT
K984502 · I-Flow Corp. · Mar 1999