510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061785Substantially Equivalent

Cyl-Fil Oxygen System

Responsive Respiratory Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061785 is the FDA 510(k) clearance record for CYL-FIL OXYGEN SYSTEM, a class I device, cleared for Responsive Respiratory, Inc. on under FDA product code CAN (Regulator, Pressure, Gas Cylinder). FDA records list 2 510(k) clearances for Responsive Respiratory, Inc., from to . As of , FDA records show no recalls naming K061785.

Clearance record

Decision date
Received
(76 days to decision)
Product code
CAN Regulator, Pressure, Gas Cylinder
Regulation
21 CFR 868.2700
Device class
Class I
Review panel
Anesthesiology
Applicant
Responsive Respiratory, Inc. 261 Wolfner Dr., St. Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAN

Trailing 12 months

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

FDA records show no clearances under product code CAN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAN, 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