510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770665Substantially Equivalent

Valve, Pressure, Demand

Mcgaw Respiratory Therapy, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770665 is the FDA 510(k) clearance record for VALVE, PRESSURE, DEMAND, a class II device, cleared for Mcgaw Respiratory Therapy on under FDA product code CBD (Bottle, Collection, Breathing System (Calibrated)). FDA records list 8 510(k) clearances for Mcgaw Respiratory Therapy, from to . As of , FDA records show no recalls naming K770665.

Clearance record

Decision date
Received
(7 days to decision)
Product code
CBD Bottle, Collection, Breathing System (Calibrated)
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Mcgaw Respiratory Therapy 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CBD

Trailing 12 months

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

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