510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811393Substantially Equivalent

Downs Cap Flow Generator

Vital Signs, Inc., East Rutherford NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811393 is the FDA 510(k) clearance record for DOWNS CAP FLOW GENERATOR, a class II device, cleared for Vital Signs, Inc. on under FDA product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). FDA records list 75 510(k) clearances for Vital Signs, Inc., from to . As of , FDA records show no recalls naming K811393.

Clearance record

Decision date
Received
(22 days to decision)
Product code
BZR Mixer, Breathing Gases, Anesthesia Inhalation
Regulation
21 CFR 868.5330
Device class
Class II
Review panel
Anesthesiology
Applicant
Vital Signs, Inc. 1 Madison St., East Rutherford NJ
Third party review
No

Clearances, product code BZR

Trailing 12 months

FDA records hold no clearances under product code BZR in the trailing twelve months.

FDA records show no clearances under product code BZR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260