Cleared Traditional

K202018 - 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 (FDA 510(k) Clearance)

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

K202018 · Hill-Rom, Inc. · Anesthesiology device
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Mar 2021
Decision
226d
Days
Class 2
Risk

K202018 is an FDA 510(k) clearance for the Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Ro.... Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on March 4, 2021 after a review of 226 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.

View all Hill-Rom, Inc. devices

Submission Details

510(k) Number K202018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2020
Decision Date March 04, 2021
Days to Decision 226 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
87d slower than avg
Panel avg: 139d · This submission: 226d
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 Peers - BZQ Monitor, Breathing Frequency

All 173
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K202018.
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093 · Linshom Medical, Inc. · Sep 2025
Respiree Cardio- Respiratory Monitor System
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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
Makani Science™ Respiration Monitoring System
K233953 · Makani Science, Inc. · Mar 2025