Cleared Traditional

K160429 - BC-5390 Auto Hematology Analyzer

K160429 is an FDA 510(k) clearance for BC-5390 Auto Hematology Analyzer, manufactured by Mindray Bio-Medical Electronics Co., Ltd.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K160429 · Mindray Bio-Medical Electronics Co., Ltd. · Hematology device
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Sep 2016
Decision
198d
Days
Class 2
Risk

K160429 is an FDA 510(k) clearance for the BC-5390 Auto Hematology Analyzer. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Mindray Bio-Medical Electronics Co., Ltd. (Nanshan, CN). The FDA issued a Cleared decision on September 1, 2016 after a review of 198 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K160429

510(k) Number K160429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date September 01, 2016
Days to Decision 198 days
Submission Type Traditional
Review Panel Hematology (HE)
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: 113d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Consultant

Biologics Consulting
Jinjie Hu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GKZ Counter, Differential Cell

All 295
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