Cleared Traditional

K200977 - Modular Toga

K200977 is the FDA 510(k) clearance for Modular Toga by Operating Room Innovations, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K200977 · Operating Room Innovations, Inc. · General Hospital
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Aug 2020
Decision
114d
Days
Class 2
Risk

K200977 is an FDA 510(k) clearance for the Modular Toga. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Operating Room Innovations, Inc. (San Diego, US). The FDA issued a Cleared decision on August 5, 2020 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Operating Room Innovations, Inc. devices

Submission Details

510(k) Number K200977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2020
Decision Date August 05, 2020
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 Consultant

Accurate Consultants, Inc.
Glen Feye

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 - FYA Gown, Surgical

All 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K200977.
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