Cleared Traditional

Oran Park Mask (K230476) - FDA 510(k) Clearance

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

K230476 · Resmed Pty Ltd (Registration Number: 3004604967) · Anesthesiology device
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Oct 2023
Decision
239d
Days
Class 2
Risk

K230476 is an FDA 510(k) clearance for the Oran Park Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed Pty Ltd (Registration Number: 3004604967) (Bella Vista, AU). The FDA issued a Cleared decision on October 19, 2023 after a review of 239 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Resmed Pty Ltd (Registration Number: 3004604967) devices

Submission Details

510(k) Number K230476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2023
Decision Date October 19, 2023
Days to Decision 239 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 140d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Resmed Corp (Registration Number: 3007573469)
Sheila Bruschi

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 - BZD Ventilator, Non-continuous (respirator)

All 123
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