Cleared Traditional

K840885 - LAKEVILLE BODY VENTILATOR

K840885 is an FDA 510(k) clearance for LAKEVILLE BODY VENTILATOR, manufactured by Edwards Ventilator Co.. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K840885 · Edwards Ventilator Co. · Anesthesiology device
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Jul 1984
Decision
136d
Days
Class 2
Risk

K840885 is an FDA 510(k) clearance for the LAKEVILLE BODY VENTILATOR. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Edwards Ventilator Co. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1984 after a review of 136 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.

FDA 510(k) Submission Details - K840885

510(k) Number K840885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date July 12, 1984
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 140d · This submission: 136d
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 K840885.
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
K840885 · LAKEVILLE BODY VENTILATOR
Download PDF Edwards Ventilator Co.