Cleared Traditional

K881808 - EMERSON CHEST RESPIRATOR, MODEL 33-CRE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881808 · J. H. Emerson Co. · Anesthesiology device
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Aug 1988
Decision
98d
Days
Class 2
Risk

K881808 is an FDA 510(k) clearance for the EMERSON CHEST RESPIRATOR, MODEL 33-CRE. 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 August 4, 1988 after a review of 98 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

Submission Details

510(k) Number K881808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1988
Decision Date August 04, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 139d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.