Cleared Traditional

K213984 - Oximeter (Model: JZK-301

K213984 is an FDA 510(k) clearance for Oximeter (Model: JZK-301, manufactured by Shenzhen Zhengkang Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K213984 · Shenzhen Zhengkang Technology Co., Ltd. · Anesthesiology device
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Dec 2022
Decision
361d
Days
Class 2
Risk

K213984 is an FDA 510(k) clearance for the Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Zhengkang Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 16, 2022 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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. Elevated predicate reliance profile. 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 Zhengkang Technology Co., Ltd. devices

FDA 510(k) Submission Details - K213984

510(k) Number K213984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2021
Decision Date December 16, 2022
Days to Decision 361 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
221d slower than avg
Panel avg: 140d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Becky Chen

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.

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All 453
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