Cleared Traditional

K170872 - Aisys CS2

K170872 is the FDA 510(k) clearance for Aisys CS2 by Datex-Ohmeda, Inc.. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K170872 · Datex-Ohmeda, Inc. · Anesthesiology device
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Aug 2017
Decision
145d
Days
Class 2
Risk

K170872 is an FDA 510(k) clearance for the Aisys CS2. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on August 15, 2017 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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.

View all Datex-Ohmeda, Inc. devices

Submission Details

510(k) Number K170872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2017
Decision Date August 15, 2017
Days to Decision 145 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
5d slower than avg
Panel avg: 140d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 101
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K170872.
A7 Anesthesia System
K171292 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2018
A5 Anesthesia System
K171311 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2018
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
K172045 · Datex-Ohmeda, Inc. · Nov 2017
Carestation 620/650/650C
K151570 · Datex-Ohmeda, Inc. · Jan 2016
A7 Anesthesia System
K151954 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
Aespire View
K143530 · Datex-Ohmeda, Inc. · Apr 2015