Cleared Traditional

K240271 - Linshom Continuous Predictive Respirato...

K240271 is an FDA 510(k) clearance for Linshom Continuous Predictive Respirato..., manufactured by Linshom Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K240271 · Linshom Medical, Inc. · Anesthesiology device
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Sep 2024
Decision
224d
Days
Class 2
Risk

K240271 is an FDA 510(k) clearance for the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Linshom Medical, Inc. (Ellicott City, US). The FDA issued a Cleared decision on September 11, 2024 after a review of 224 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 Linshom Medical, Inc. devices

FDA 510(k) Submission Details - K240271

510(k) Number K240271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2024
Decision Date September 11, 2024
Days to Decision 224 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 140d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

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 77
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K240271.
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