Cleared Traditional

K040710 - TEGO NEEDLE FREE ACCESS ACCESS DEVICE

K040710 is the FDA 510(k) clearance for TEGO NEEDLE FREE ACCESS ACCESS DEVICE by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K040710 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
146d
Days
Class 2
Risk

K040710 is an FDA 510(k) clearance for the TEGO NEEDLE FREE ACCESS ACCESS DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 11, 2004 after a review of 146 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K040710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2004
Decision Date August 11, 2004
Days to Decision 146 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
17d slower than avg
Panel avg: 129d · This submission: 146d
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 445
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K040710.
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936 · Baxter Healthcare Corp · Nov 2004
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
K041490 · B.Braun Medical, Inc. · Oct 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
K042182 · Icu Medical, Inc. · Sep 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410 · Icu Medical, Inc. · Jul 2004
SPLIT SEPTUM INJECTION SITES
K041042 · Fresenius Medical Care North America · Jul 2004
TALON INFUSION SET, MODEL IP XXXX
K033290 · Icu Medical, Inc. · Apr 2004