Cleared Traditional

The RHEA Vital Sign Vigilance System (K190775) - FDA 510(k) Clearance

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

K190775 · Shenzhen Fiber Medical Technology Co. , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
268d
Days
Class 2
Risk

K190775 is an FDA 510(k) clearance for the The RHEA Vital Sign Vigilance System. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Shenzhen Fiber Medical Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 19, 2019 after a review of 268 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 Shenzhen Fiber Medical Technology Co. , Ltd. devices

Submission Details

510(k) Number K190775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2019
Decision Date December 19, 2019
Days to Decision 268 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
129d slower than avg
Panel avg: 139d · This submission: 268d
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

Biologics Consulting Group
Donna-Bea Tillman

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
NCT03332147 Completed Interventional Industry-sponsored

Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients

Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients

80
Patients (actual)
3
Sites
Screening
Purpose
Open label
Masking
Condition studied Vital Sign Monitoring
Study design Crossover
Eligibility All sexes
Principal investigator Judith Cullinane, MSN
Sponsor Darma Inc. (industry)
Started 2017-11-04 → Primary completion 2018-05-25 → Completed 2018-06-30
Primary outcome
RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
Secondary outcome
Heart Rate t Test Comparison result between the Investigational Device and the Reference Device
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
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 K190775.
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
Makani Science™ Respiration Monitoring System
K233953 · Makani Science, Inc. · Mar 2025