Cleared Traditional

K220107 - Mindray SV600 Ventilator, Mindray SV800 Ventilator (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220107 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology device

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Jun 2023

Decision

520d

Days

Class 2

Risk

K220107 is an FDA 510(k) clearance for the Mindray SV600 Ventilator, Mindray SV800 Ventilator. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 16, 2023 after a review of 520 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K220107 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 12, 2022
Decision Date	June 16, 2023
Days to Decision	520 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

381d slower than avg

Panel avg: 139d · This submission: 520d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CBK Ventilator, Continuous, Facility Use
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5895

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.