Cleared Traditional

K760339 - MONITOR, RESPIRATORY (CPAP)

K760339 is an FDA 510(k) clearance for MONITOR, manufactured by Sherwood Medical Industries. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K760339 · Sherwood Medical Industries · Anesthesiology device
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Oct 1976
Decision
90d
Days
Class 2
Risk

K760339 is an FDA 510(k) clearance for the MONITOR, RESPIRATORY (CPAP). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on October 28, 1976 after a review of 90 days - within the typical 510(k) review window.

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 Sherwood Medical Industries devices

FDA 510(k) Submission Details - K760339

510(k) Number K760339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1976
Decision Date October 28, 1976
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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.