Cleared Traditional

K811393 - DOWNS CAP FLOW GENERATOR

K811393 is the FDA 510(k) clearance for DOWNS CAP FLOW GENERATOR by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BZR) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K811393 · Vital Signs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
22d
Days
Class 2
Risk

K811393 is an FDA 510(k) clearance for the DOWNS CAP FLOW GENERATOR. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Vital Signs, Inc. (East Rutherford, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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 K811393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1981
Decision Date June 09, 1981
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 21
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K811393.
SIEMENS O2-AIR MIXER 965
K872278 · Siemens Elema AB · Sep 1987
OHMEDA OXYGEN BLENDER
K853905 · Ohmeda Medical · Oct 1985
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
K841789 · Shiley, Inc. · Jul 1984
SIEMENS-ELEMA AB O2-AIR MIXER 960
K800905 · Siemens Elema AB · May 1980
DRAGER ORMC
K800764 · Draeger Medical, Inc. · Apr 1980