Cleared Traditional

K980089 - 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000

K980089 is an FDA 510(k) clearance for 3600 PRESURE INFUSOR, manufactured by Valley West, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K980089 · Valley West, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
74d
Days
Class 2
Risk

K980089 is an FDA 510(k) clearance for the 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000. 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 March 24, 1998 after a review of 74 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

FDA 510(k) Submission Details - K980089

510(k) Number K980089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1998
Decision Date March 24, 1998
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 529
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