Cleared Traditional

K802070 - VITAL SIGNS PEEP VALVE

K802070 is the FDA 510(k) clearance for VITAL SIGNS PEEP VALVE by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K802070 · Vital Signs, Inc. · Anesthesiology device
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Sep 1980
Decision
13d
Days
Class 2
Risk

K802070 is an FDA 510(k) clearance for the VITAL SIGNS PEEP VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Vital Signs, Inc. (East Rutherford, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 13 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K802070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1980
Decision Date September 09, 1980
Days to Decision 13 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
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K802070.
PEEP SYSTEM D
K831301 · Draeger Medical, Inc. · Jun 1983
PEEP VALVE
K820404 · Vital Signs, Inc. · Mar 1982
DRAGER PEEP CONTROL SYSTEM
K802707 · Draeger Medical, Inc. · Nov 1980
BOEHRINGER LABS AMBULATORY PEEP VALVE
K800755 · Boehringer Laboratories · May 1980
VALVE, PEEP
K760230 · Ohio Medical Products · Aug 1976