Cleared Traditional

K831877 - ARF 850 E

K831877 is an FDA 510(k) clearance for ARF 850 E, manufactured by W.E. Leder Enterprises, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K831877 · W.E. Leder Enterprises, Inc. · Anesthesiology device
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Nov 1983
Decision
143d
Days
Class 2
Risk

K831877 is an FDA 510(k) clearance for the ARF 850 E. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by W.E. Leder Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 W.E. Leder Enterprises, Inc. devices

FDA 510(k) Submission Details - K831877

510(k) Number K831877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date November 03, 1983
Days to Decision 143 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 140d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 421
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K831877.
VOLUME VENTILATOR
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PNEU PAC VENTILATOR/RESUSCITATORS
K832700 · Pneupac , Ltd. · Nov 1983
PORTABLE LIFECARE VENTILATOR PLV-100
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PZ-800 VOLUME VENTILATOR
K822835 · Narco Scientific · Sep 1983
VENTILATOR #1
K830488 · Ohio Medical Products · Sep 1983