Cleared Traditional

K800755 - BOEHRINGER LABS AMBULATORY PEEP VALVE

K800755 is an FDA 510(k) clearance for BOEHRINGER LABS AMBULATORY PEEP VALVE, manufactured by Boehringer Laboratories. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K800755 · Boehringer Laboratories · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1980
Decision
34d
Days
Class 2
Risk

K800755 is an FDA 510(k) clearance for the BOEHRINGER LABS AMBULATORY PEEP VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Boehringer Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 Boehringer Laboratories devices

FDA 510(k) Submission Details - K800755

510(k) Number K800755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1980
Decision Date May 08, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 48
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K800755.
PEEP VALVE
K820404 · Vital Signs, Inc. · Mar 1982
DRAGER PEEP CONTROL SYSTEM
K802707 · Draeger Medical, Inc. · Nov 1980
VITAL SIGNS PEEP VALVE
K802070 · Vital Signs, Inc. · Sep 1980
VALVE, AMBU PEEP
K782152 · Narco Air-Shields · Dec 1978
PEEP/CPAP VALVE
K781332 · Vickers America Medical Corp. · Oct 1978
VALVE, PEEP
K760230 · Ohio Medical Products · Aug 1976