Cleared Traditional

K151570 - Carestation 620/650/650C

K151570 is an FDA 510(k) clearance for Carestation 620/650/650C, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K151570 · Datex-Ohmeda, Inc. · Anesthesiology device
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Jan 2016
Decision
225d
Days
Class 2
Risk

K151570 is an FDA 510(k) clearance for the Carestation 620/650/650C. 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 January 21, 2016 after a review of 225 days - an extended review cycle.

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

FDA 510(k) Submission Details - K151570

510(k) Number K151570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2015
Decision Date January 21, 2016
Days to Decision 225 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
85d slower than avg
Panel avg: 140d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K151570.
A5 Anesthesia System
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K172045 · Datex-Ohmeda, Inc. · Nov 2017
Aisys CS2
K170872 · Datex-Ohmeda, Inc. · Aug 2017
A7 Anesthesia System
K151954 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
Aespire View
K143530 · Datex-Ohmeda, Inc. · Apr 2015
A7 Anesthesia System
K142552 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2015