Cleared Traditional

K220739 - Disposable Urine Collection Tube (FDA 510(k) Clearance)

Class I Microbiology device.

K220739 · Zhejiang Gongdong Medical Technology Co., Ltd. · Microbiology device
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Nov 2022
Decision
248d
Days
Class 1
Risk

K220739 is an FDA 510(k) clearance for the Disposable Urine Collection Tube. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Zhejiang Gongdong Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on November 17, 2022 after a review of 248 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Gongdong Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K220739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2022
Decision Date November 17, 2022
Days to Decision 248 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 102d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Shanghai Mind-Link Consulting Co., Ltd.
Evan 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.

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