Cleared Traditional

K831503 - DOWNS ADJUSTABLE FLOW GENERATOR

K831503 is an FDA 510(k) clearance for DOWNS ADJUSTABLE FLOW GENERATOR, manufactured by Vital Signs, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K831503 · Vital Signs, Inc. · Anesthesiology device
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Sep 1983
Decision
124d
Days
Class 2
Risk

K831503 is an FDA 510(k) clearance for the DOWNS ADJUSTABLE FLOW GENERATOR. 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 12, 1983 after a review of 124 days - within the typical 510(k) review window.

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: 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K831503

510(k) Number K831503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date September 12, 1983
Days to Decision 124 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
16d faster than avg
Panel avg: 140d · This submission: 124d
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 65
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K831503.
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889 · Respironics, Inc. · Dec 1984
OHMEDA PEEP VALVE FOR GMS ABSORBER
K843835 · Ohmeda Medical · Nov 1984
DRAGER PEEP SYSTEM D
K834085 · Draeger Medical, Inc. · Dec 1983
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