Cleared Traditional

K894649 - EMERSON 33-CR CHEST RESPIRATOR

K894649 is the FDA 510(k) clearance for EMERSON 33-CR CHEST RESPIRATOR by Emerson Intl. Co.. It is a Class 2 Anesthesiology device (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.

View all Emerson Intl. Co. devices

Submission Details

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
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.

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.

Regulatory Peers - BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)

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