Cleared Traditional

K201816 - ARTHROTAP

K201816 is the FDA 510(k) clearance for ARTHROTAP by Accuro Technologies, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K201816 · Accuro Technologies, Inc. · General Hospital
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Oct 2020
Decision
107d
Days
Class 2
Risk

K201816 is an FDA 510(k) clearance for the ARTHROTAP. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Accuro Technologies, Inc. (Victoria, CA). The FDA issued a Cleared decision on October 16, 2020 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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. Standard predicate reliance. 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 Accuro Technologies, Inc. devices

Submission Details

510(k) Number K201816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2020
Decision Date October 16, 2020
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Peers - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K201816.
Insulin Syringe
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K193526 · Jiangsu Caina Medical Co.,Ltd · Jul 2020
BD SoloShot Mini Syringe/ BD Auto Disable Syringe
K201234 · Becton, Dickinson and Company · Jul 2020