Cleared Traditional

Disposable IV catheter (K202060) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202060 · Shinva Ande Healthcare Apparatus Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
361d
Days
Class 2
Risk

K202060 is an FDA 510(k) clearance for the Disposable IV catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Shinva Ande Healthcare Apparatus Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on July 23, 2021 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shinva Ande Healthcare Apparatus Co., Ltd. devices

Submission Details

510(k) Number K202060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date July 23, 2021
Days to Decision 361 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 129d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 130
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K202060.
Pluski Safe 1 Safety IV Catheter
K210037 · Mediplus (India) Limited · Mar 2022
B. Braun Introcan Safety 2 IV Catheter
K213664 · B.Braun Medical, Inc. · Feb 2022
Introcan Safety 3 Closed IV Catheter
K213085 · B.Braun Medical, Inc. · Oct 2021
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
K200891 · Becton, Dickinson and Company · Jun 2021
HydroMID
K203069 · Access Vascular, Inc. · Feb 2021
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
K201075 · Becton, Dickinson and Company · Dec 2020