Cleared Traditional

K190734 - Linshom Respiratory Monitoring Device (...

K190734 is the FDA 510(k) clearance for Linshom Respiratory Monitoring Device (... by Linshom Management, LLC. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K190734 · Linshom Management, LLC · Anesthesiology device
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Jan 2020
Decision
315d
Days
Class 2
Risk

K190734 is an FDA 510(k) clearance for the Linshom Respiratory Monitoring Device (LRMD). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Linshom Management, LLC (Ellicott City, US). The FDA issued a Cleared decision on January 30, 2020 after a review of 315 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Linshom Management, LLC devices

Submission Details

510(k) Number K190734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2019
Decision Date January 30, 2020
Days to Decision 315 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
175d slower than avg
Panel avg: 140d · This submission: 315d
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 59
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K190734.
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
The RHEA Vital Sign Vigilance System
K190775 · Shenzhen Fiber Medical Technology Co. , Ltd. · Dec 2019
Masimo Acoustic Respiration Sensors, infant and neonate
K173976 · Masimo Corporation · Sep 2018
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
K180079 · Hill-Rom, Inc. · May 2018