Cleared Traditional

K881689 - LINDLEY II RESUSCITATOR

K881689 is the FDA 510(k) clearance for LINDLEY II RESUSCITATOR by Lindley Resuscitator, Inc.. It is a Class 2 Anesthesiology device (product code BYT) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K881689 · Lindley Resuscitator, Inc. · Anesthesiology device
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Jul 1988
Decision
80d
Days
Class 2
Risk

K881689 is an FDA 510(k) clearance for the LINDLEY II RESUSCITATOR. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Lindley Resuscitator, Inc. (Meridian, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 80 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 Lindley Resuscitator, Inc. devices

Submission Details

510(k) Number K881689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1988
Decision Date July 08, 1988
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
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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