Cleared Traditional

K182274 - Orbit Subretinal Delivery System (FDA 510(k) Clearance)

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

K182274 · Orbit Biomedical, Inc. · Ophthalmic device
Nov 2018
Decision
90d
Days
Class 2
Risk

K182274 is an FDA 510(k) clearance for the Orbit Subretinal Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Orbit Biomedical, Inc. (Ambler, US). The FDA issued a Cleared decision on November 20, 2018 after a review of 90 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K182274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 22, 2018
Decision Date November 20, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 156d · This submission: 90d
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 Peers - FMF Syringe, Piston

All 29
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K182274.
Profoject™ Insulin Syringes
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EXEL Disposable Syringe
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Verisafe Safety Retractable Insulin Syringes
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Merit Syringe
K250853 · Merit Medical Systems, Inc. · Nov 2025