Cleared Traditional

K002449 - BIOTEQ I.V. (INTRAVENOUS) SET

K002449 is the FDA 510(k) clearance for BIOTEQ I.V. (INTRAVENOUS) SET by Bioteque Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K002449 · Bioteque Corp. · General Hospital
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Dec 2000
Decision
135d
Days
Class 2
Risk

K002449 is an FDA 510(k) clearance for the BIOTEQ I.V. (INTRAVENOUS) SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Bioteque Corp. (Flaggstaff, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 135 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 Bioteque Corp. devices

Submission Details

510(k) Number K002449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2000
Decision Date December 22, 2000
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 375
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K002449.
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
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TAXOL ADMINISTRATION SET
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K003225 · Baxter Healthcare Corp · Oct 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000
POSI-LINK
K000472 · Icu Medical, Inc. · May 2000