Cleared Traditional

K881808 - EMERSON CHEST RESPIRATOR

K881808 is an FDA 510(k) clearance for EMERSON CHEST RESPIRATOR, 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 98-day FDA review.

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

FDA 510(k) Submission Details - K881808

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
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 K881808.
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
K905530 · Puritan Bennett Corp. · Mar 1991
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
K902764 · J. H. Emerson Co. · Nov 1990
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · Respironics, Inc. · Dec 1989
Q101 DIAGNOSTIC SPIROMETER
K863300 · Quinton, Inc. · Nov 1986
PTR MK II VENTILATOR
K860692 · Bear Medical Systems, Inc. · May 1986
NEGATIVE PRESSURE CHEST RESPIRATOR PUMP
K832176 · J. H. Emerson Co. · Sep 1983