Cleared Traditional

K002689 - SWABSITE SWABBABLE VALVE, MODEL 245000

K002689 is an FDA 510(k) clearance for SWABSITE SWABBABLE VALVE, manufactured by Quest Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K002689 · Quest Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
189d
Days
Class 2
Risk

K002689 is an FDA 510(k) clearance for the SWABSITE SWABBABLE VALVE, MODEL 245000. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on March 6, 2001 after a review of 189 days - an extended review 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: 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.

FDA 510(k) Submission Details - K002689

510(k) Number K002689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2000
Decision Date March 06, 2001
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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 1172
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K002689.
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SURSHIELD WINGED INFUSION SET
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DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET
K003977 · Disetronic Medical Systems AG · Feb 2001
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
K001329 · Lifemed of California · Feb 2001
INTRAVASCULAR ADMINISTRATION SET
K003854 · Infusion Devices, Inc. · Feb 2001
K002689 · SWABSITE SWABBABLE VALVE, MODEL 245000
Download PDF FDA Summary Quest Medical, Inc.