Cleared Traditional

K983217 - ROWE DUAL-CHECK VALVE

K983217 is an FDA 510(k) clearance for ROWE DUAL-CHECK VALVE, manufactured by Cook, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K983217 · Cook, Inc. · General Hospital
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Jan 1999
Decision
128d
Days
Class 2
Risk

K983217 is an FDA 510(k) clearance for the ROWE DUAL-CHECK VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 20, 1999 after a review of 128 days - within the typical 510(k) review window.

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: 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 Cook, Inc. devices

FDA 510(k) Submission Details - K983217

510(k) Number K983217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date January 20, 1999
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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 773
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K983217.
PARAGON INFUSION
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SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
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MPS GRAVITY FLOW CONTROL SET
K983926 · Critical Device Corp. · Jan 1999
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
K983073 · Integra Biotechnical, LLC · Dec 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672 · Baxter Healthcare Corp · Sep 1998