Cleared Traditional

RespiraSense (K220111) - FDA 510(k) Clearance

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

K220111 · Pmd Solutions · Anesthesiology device
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Oct 2022
Decision
267d
Days
Class 2
Risk

K220111 is an FDA 510(k) clearance for the RespiraSense. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Pmd Solutions (Cork, IE). The FDA issued a Cleared decision on October 7, 2022 after a review of 267 days - an extended review cycle.

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: 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.

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Submission Details

510(k) Number K220111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2022
Decision Date October 07, 2022
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

ProMedic Consulting, LLC
Paul Dryden

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 - BZQ Monitor, Breathing Frequency

All 34
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K220111.
Respiree Cardio-Respiratory Monitor
K223681 · Respiree Pte, Ltd. · Mar 2023
Dozee VS
K221555 · Turtle Shell Technologies Private Limited · Dec 2022
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K223246 · Baxter Healthcare Corproration · Nov 2022
Breathe Easy Mobile Respiratory Monitor (MRM)
K211387 · Sound Life Sciences, Inc. · Nov 2021
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
K202018 · Hill-Rom, Inc. · Mar 2021
The C100 Contactless Breathing Monitor
K200445 · Circadia Technologies, Ltd. · Jun 2020