Cleared Traditional

Prefilled Syringe (K202698) - FDA 510(k) Clearance

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

K202698 · Hangzhou Primecare Medical Co., Ltd. · Gastroenterology & Urology device
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Dec 2020
Decision
90d
Days
Class 2
Risk

K202698 is an FDA 510(k) clearance for the Prefilled Syringe. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Hangzhou Primecare Medical Co., Ltd. (Hang Zhou, CN). The FDA issued a Cleared decision on December 15, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hangzhou Primecare Medical Co., Ltd. devices

Submission Details

510(k) Number K202698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2020
Decision Date December 15, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Guangzhou Osmunda Medical Device Technical Services Co., Ltd.
Olivia Meng

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 - EZL Catheter, Retention Type, Balloon

All 42
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K202698.
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K182463 · Biosensors International Pte, Ltd. · Nov 2019