Cleared Traditional

K220739 - Disposable Urine Collection Tube

K220739 is an FDA 510(k) clearance for Disposable Urine Collection Tube, manufactured by Zhejiang Gongdong Medical Technology Co., Ltd.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 248-day FDA review.

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

FDA 510(k) Submission Details - K220739

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.

JSM Device Classification - Class 1, General Controls

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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 58
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K220739.
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