510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K072469Substantially Equivalent

Digiflo Concentrator Analyzer

Digiflo, Inc., Mercer Island WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072469 is the FDA 510(k) clearance record for DIGIFLO CONCENTRATOR ANALYZER, a class II device, cleared for Digiflo, Inc. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list one 510(k) clearance for Digiflo, Inc. As of , FDA records show no recalls naming K072469.

Clearance record

Decision date
Received
(121 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Digiflo, Inc. 6942 96th Ave. SE, Mercer Island WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260