Cleared Traditional

K002689 - SWABSITE SWABBABLE VALVE

K002689 is the FDA 510(k) clearance for SWABSITE SWABBABLE VALVE by Quest Medical, Inc.. It is a Class 2 General Hospital device (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)
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.

View all Quest Medical, Inc. devices

Submission Details

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.

Device Classification

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 448
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K002689.
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · Terumo Medical Corp. · Oct 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · Northgate Technologies, Inc. · Aug 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
TAXOL ADMINISTRATION SET
K003513 · Icu Medical, Inc. · Jan 2001
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · Baxter Healthcare Corp · Oct 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000