Cleared Traditional

1000 PRESSURE INFUSION SIGMACON 1000 (K990447) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990447 · Valley West, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
89d
Days
Class 2
Risk

K990447 is an FDA 510(k) clearance for the 1000 PRESSURE INFUSION SIGMACON 1000. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Valley West, Inc. (Meridian, US). The FDA issued a Cleared decision on May 12, 1999 after a review of 89 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 Valley West, Inc. devices

Submission Details

510(k) Number K990447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1999
Decision Date May 12, 1999
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K990447.
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
ACCLAIM INFUSION PUMP
K991501 · Abbott Laboratories · May 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · Abbott Laboratories · Mar 1998