Cleared Traditional

K902764 - EMERSON 33-AN NEGATIVE PRESSURE RESPIRA...

K902764 is an FDA 510(k) clearance for EMERSON 33-AN NEGATIVE PRESSURE RESPIRA..., manufactured by J. H. Emerson Co.. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K902764 · J. H. Emerson Co. · Anesthesiology device
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Nov 1990
Decision
147d
Days
Class 2
Risk

K902764 is an FDA 510(k) clearance for the EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Cambridge, US). The FDA issued a Cleared decision on November 19, 1990 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5935 - 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 J. H. Emerson Co. devices

FDA 510(k) Submission Details - K902764

510(k) Number K902764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1990
Decision Date November 19, 1990
Days to Decision 147 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
7d slower than avg
Panel avg: 140d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYT Device Classification - Class 2, Special Controls

Product Code BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5935
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 - BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)

All 7
Devices cleared under the same product code (BYT) and FDA review panel - the closest regulatory comparables to K902764.
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