Cleared Traditional

K894649 - EMERSON 33-CR CHEST RESPIRATOR

K894649 is an FDA 510(k) clearance for EMERSON 33-CR CHEST RESPIRATOR, manufactured by Emerson Intl. Co.. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K894649 · Emerson Intl. Co. · Anesthesiology device
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Oct 1989
Decision
81d
Days
Class 2
Risk

K894649 is an FDA 510(k) clearance for the EMERSON 33-CR CHEST RESPIRATOR. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Emerson Intl. Co. (Cambridge, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K894649

510(k) Number K894649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date October 13, 1989
Days to Decision 81 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
59d faster than avg
Panel avg: 140d · This submission: 81d
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 15
Devices cleared under the same product code (BYT) and FDA review panel - the closest regulatory comparables to K894649.
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
K902764 · J. H. Emerson Co. · Nov 1990
EASY BREATHER MODEL 100 ACCESSORIES
K902300 · Progressive Productions , Ltd. · Jul 1990
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · Respironics, Inc. · Dec 1989
EASY BREATHER MODEL 100
K893213 · Progressive Productions , Ltd. · Aug 1989
EMERSON CHEST RESPIRATOR, MODEL 33-CRE
K881808 · J. H. Emerson Co. · Aug 1988
Q101 DIAGNOSTIC SPIROMETER
K863300 · Quinton, Inc. · Nov 1986
K894649 · EMERSON 33-CR CHEST RESPIRATOR
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