Cleared Traditional

MicroDose Injector (K203264) - FDA 510(k) Clearance

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

K203264 · Medone Surgical, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Apr 2021
Decision
172d
Days
Class 2
Risk

K203264 is an FDA 510(k) clearance for the MicroDose Injector. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medone Surgical, Inc. (Sarasota, US). The FDA issued a Cleared decision on April 26, 2021 after a review of 172 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5860 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medone Surgical, Inc. devices

Submission Details

510(k) Number K203264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2020
Decision Date April 26, 2021
Days to Decision 172 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 110d · This submission: 172d
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 Ophthalmic devices follow this clearance model.

Regulatory Consultant

Elkin Rc, LLC
Darla Elkin

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 - FMF Syringe, Piston

All 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K203264.
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BD Hypodermic Syringe
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Nanum Syringe
K201930 · Nanum Company Co., Ltd. · Jan 2021