Cleared Traditional

K142552 - A7 Anesthesia System

K142552 is an FDA 510(k) clearance for A7 Anesthesia System, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K142552 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology device
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Jan 2015
Decision
135d
Days
Class 2
Risk

K142552 is an FDA 510(k) clearance for the A7 Anesthesia System. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 23, 2015 after a review of 135 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K142552

510(k) Number K142552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2014
Decision Date January 23, 2015
Days to Decision 135 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 faster than avg
Panel avg: 140d · This submission: 135d
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 134
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K142552.
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