Cleared Traditional

K233953 - Makani Science™ Respiration Monitoring System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K233953 · Makani Science, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
469d
Days
Class 2
Risk

K233953 is an FDA 510(k) clearance for the Makani Science™ Respiration Monitoring System. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Makani Science, Inc. (Irvine, US). The FDA issued a Cleared decision on March 28, 2025 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Makani Science, Inc. devices

Submission Details

510(k) Number K233953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date March 28, 2025
Days to Decision 469 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
330d slower than avg
Panel avg: 139d · This submission: 469d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Speed TO Market, Inc.
Thomas Kroenke

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.

Clinical Evidence

ClinicalTrials.gov
NCT06000852 Completed Interventional Industry-sponsored

Comparison of Non-Invasive Respiratory Monitoring System (RMS)

Makani Science Respiration Monitoring System Pivotal Clinical Study Protocol

27
Patients (actual)
Basic_science
Purpose
Open label
Masking
Condition studied Respiratory Monitoring
Study design Single group
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Michael Chu (industry)
Started 2022-08-03 → Primary completion 2022-10-29
Primary outcome
Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
Secondary outcome
Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
View full study on ClinicalTrials.gov

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 173
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K233953.
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093 · Linshom Medical, Inc. · Sep 2025
Respiree Cardio- Respiratory Monitor System
K250934 · Respiree Pte, Ltd. · Aug 2025
RTMsense Respiratory Monitoring System
K243183 · Rtm Vital Signs, LLC · Jun 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K243966 · Faceheart Corp. · Apr 2025
Philips VSC-MEDlib
K242001 · Philips Medical Systems Nederland B.V. · Apr 2025
Airmod
K242798 · Heroic Faith International , Ltd. · Feb 2025