Cleared Traditional

CONTINUUM PACS (K200385) - FDA 510(k) Clearance

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

K200385 · Integrated Ophthalmic Systems, Inc. · Ophthalmic device
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Mar 2020
Decision
27d
Days
Class 2
Risk

K200385 is an FDA 510(k) clearance for the CONTINUUM PACS. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Integrated Ophthalmic Systems, Inc. (Woburn, US). The FDA issued a Cleared decision on March 16, 2020 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integrated Ophthalmic Systems, Inc. devices

Submission Details

510(k) Number K200385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2020
Decision Date March 16, 2020
Days to Decision 27 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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

Accelerated Device Approval Services
Rafael Aguila

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 - NFJ System, Image Management, Ophthalmic

All 51
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