Cleared Abbreviated

K062308 - LMT-KATH-S

Also marketed or referenced as:
LMT-KATH-I

K062308 is an FDA 510(k) clearance for LMT-KATH-S, manufactured by Licher Medizintechnologie GmbH. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 224-day FDA review.

K062308 · Licher Medizintechnologie GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
224d
Days
Class 2
Risk

K062308 is an FDA 510(k) clearance for the LMT-KATH-S. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Licher Medizintechnologie GmbH (Wedemark, DE). The FDA issued a Cleared decision on March 20, 2007 after a review of 224 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Licher Medizintechnologie GmbH devices

FDA 510(k) Submission Details - K062308

510(k) Number K062308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2006
Decision Date March 20, 2007
Days to Decision 224 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 129d · This submission: 224d
Pathway characteristics
Standards-based clearance path.

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 699
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K062308.
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
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SURFLO WINGED INFUSION SET
K070362 · Terumo Europe N.V. · May 2007
SPIROS
K070532 · Icu Medical, Inc. · Mar 2007
EZ-CONNECT
K061771 · Vidacare Corporation · Jul 2006
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074 · Baxter Healthcare Corp · Mar 2006