Cleared Traditional

S10 Kirra (K203126) - FDA 510(k) Clearance

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

K203126 · Resmed Pty , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
60d
Days
Class 2
Risk

K203126 is an FDA 510(k) clearance for the S10 Kirra. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed Pty , Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on December 18, 2020 after a review of 60 days - a notably fast clearance 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: 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 Resmed Pty , Ltd. devices

Submission Details

510(k) Number K203126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2020
Decision Date December 18, 2020
Days to Decision 60 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
80d faster than avg
Panel avg: 140d · This submission: 60d
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
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 130
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K203126.
Innova Nasal Non-Vented Mask
K203601 · Sleepnet Corporation · Apr 2021
Luna® G3 BPAP 25A
K201620 · 3B Medical, Inc. · Jan 2021
Galapogos
K200565 · ResMed Corp · Jan 2021
SysMed S/T
K192177 · Sysmed (China) Co., Ltd. · Nov 2020
WiZARD 510 Nasal Mask
K193206 · Apex Medical Corp. · Oct 2020
Ventilator, Non-continuous (Respirator)
K201439 · Respironics, Inc. · Sep 2020