Cleared Special

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense (K223246) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223246 · Baxter Healthcare Corproration · Anesthesiology device
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Nov 2022
Decision
29d
Days
Class 2
Risk

K223246 is an FDA 510(k) clearance for the Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Baxter Healthcare Corproration (Batesville, US). The FDA issued a Cleared decision on November 18, 2022 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxter Healthcare Corproration devices

Submission Details

510(k) Number K223246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2022
Decision Date November 18, 2022
Days to Decision 29 days
Submission Type Special
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
110d faster than avg
Panel avg: 139d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 Peers - BZQ Monitor, Breathing Frequency

All 23
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K223246.
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K240271 · Linshom Medical, Inc. · Sep 2024
Respiree Cardio-Respiratory Monitor
K223681 · Respiree Pte, Ltd. · Mar 2023
Dozee VS
K221555 · Turtle Shell Technologies Private Limited · Dec 2022
RespiraSense
K220111 · Pmd Solutions · Oct 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