Cleared Traditional

K230501 - Spirobank Oxi

K230501 is an FDA 510(k) clearance for Spirobank Oxi, manufactured by Mir Medical International Research USA. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K230501 · Mir Medical International Research USA · Anesthesiology device
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Dec 2023
Decision
294d
Days
Class 2
Risk

K230501 is an FDA 510(k) clearance for the Spirobank Oxi. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Mir Medical International Research USA (New Berlin, US). The FDA issued a Cleared decision on December 15, 2023 after a review of 294 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Mir Medical International Research USA devices

FDA 510(k) Submission Details - K230501

510(k) Number K230501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2023
Decision Date December 15, 2023
Days to Decision 294 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
154d slower than avg
Panel avg: 140d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 Peers - BZG Spirometer, Diagnostic

All 49
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K230501.
MESI mTABLET SPIRO
K251777 · Mesi D.O.O. · Mar 2026
TD-7301 Spirometer (TD-7301)
K241843 · Gostar Co., Ltd. · Nov 2024
Air Next (NVD-02)
K231416 · Nuvoair AB · Jan 2024
EasyOne Sky Spirometer
K230178 · Ndd Medizintechnik AG · Oct 2023
Alveoair Digital Spirometer
K222525 · Roundworks Technologies Private Limited · Aug 2023
Air Smart Extra Spirometer
K222443 · Feellife Health, Inc. · Aug 2023