Cleared Traditional

K141255 - SIMEX SUBGLOTTIC ASPIRATION SYSTEM

K141255 is an FDA 510(k) clearance for SIMEX SUBGLOTTIC ASPIRATION SYSTEM, manufactured by Simex Medizintechnik GmbH. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K141255 · Simex Medizintechnik GmbH · General & Plastic Surgery device
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Sep 2014
Decision
131d
Days
Class 2
Risk

K141255 is an FDA 510(k) clearance for the SIMEX SUBGLOTTIC ASPIRATION SYSTEM. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Simex Medizintechnik GmbH (Tarrytown, US). The FDA issued a Cleared decision on September 22, 2014 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Simex Medizintechnik GmbH devices

FDA 510(k) Submission Details - K141255

510(k) Number K141255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2014
Decision Date September 22, 2014
Days to Decision 131 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 78
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K141255.
Model 330 Multifunction Aspirator
K170533 · ZOLL Medical Corporation · Apr 2017
Aprima Smartesis Centesis Pump
K161002 · Cook Incorporated · Sep 2016
Vario 8/18/ci
K153663 · Medela AG · May 2016
MEDELA THOPAZ+
K141553 · Medela AG · Aug 2014
EASY GO VAC
K140179 · Precision Medical, Inc. · Apr 2014
BASIC AND DOMINANT FLEX SUCTION PUMPS
K130123 · Medela AG · Oct 2013