Cleared Traditional

K041917 - PLASIATEK ACTUATOR

K041917 is an FDA 510(k) clearance for PLASIATEK ACTUATOR, manufactured by Plasiatek, LLC. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K041917 · Plasiatek, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
175d
Days
Class 2
Risk

K041917 is an FDA 510(k) clearance for the PLASIATEK ACTUATOR. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Plasiatek, LLC (Minneapolis, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 175 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K041917

510(k) Number K041917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2004
Decision Date January 07, 2005
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 204
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K041917.
PEDIATRIC CUFFED AND UNCUFFED ET TUBES
K050803 · Vitaid, Ltd. · Jun 2005
TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)
K041311 · Tiger Medical Products, Ltd. · Mar 2005
WELL LEAD ENDOTRACHEAL TUBE
K042683 · Well Lead Medical Instruments · Feb 2005
RUSCH EASY TUBE
K043205 · Teleflex Medical · Jan 2005
BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
K040657 · Vygon SA · Jun 2004
ENDOFLEX TRACHEAL TUBE
K031794 · Merlyn Associates, Inc. · Mar 2004