Cleared Traditional

K841090 - VENTILATOR EXTERNAL BODY NEGATIVE PRESS

K841090 is an FDA 510(k) clearance for VENTILATOR EXTERNAL BODY NEGATIVE PRESS, manufactured by Porta-Lung Co.. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K841090 · Porta-Lung Co. · Anesthesiology device
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May 1984
Decision
78d
Days
Class 2
Risk

K841090 is an FDA 510(k) clearance for the VENTILATOR EXTERNAL BODY NEGATIVE PRESS. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Porta-Lung Co. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 78 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 - K841090

510(k) Number K841090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1984
Decision Date May 30, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
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 17
Devices cleared under the same product code (BYT) and FDA review panel - the closest regulatory comparables to K841090.
EMERSON CHEST RESPIRATOR, MODEL 33-CRE
K881808 · J. H. Emerson Co. · Aug 1988
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
CAM-10 CUIRASS SHELL
K792673 · Lifecare Services, Inc. · Jan 1980
CAM-10 CHEST SHELL
K791406 · Lifecare Services, Inc. · Aug 1979
K841090 · VENTILATOR EXTERNAL BODY NEGATIVE PRESS
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