Cleared Traditional

K200325 - Orbit Subretinal Delivery System

K200325 is the FDA 510(k) clearance for Orbit Subretinal Delivery System by Orbit Biomedical. It is a Class 2 Ophthalmic device (product code FMF) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K200325 · Orbit Biomedical · Ophthalmic device
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Jul 2020
Decision
155d
Days
Class 2
Risk

K200325 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 (Ambler, US). The FDA issued a Cleared decision on July 14, 2020 after a review of 155 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 Orbit Biomedical devices

Submission Details

510(k) Number K200325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2020
Decision Date July 14, 2020
Days to Decision 155 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
45d slower than avg
Panel avg: 110d · This submission: 155d
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

Clinreg Cnsulting Services, Inc.
Debe Deck

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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K200325.
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Allograft MIS Delivery System
K201338 · Lifenet Health · Jul 2020
Aspire Mechanical Aspirator G
K200629 · Control Medical Technology · May 2020
3D GraftRasp System
K200431 · Surgentec · May 2020