510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854571Substantially Equivalent

Demand Flow Valve & Sonra W/nasal Mask

Gale E. Dryden, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854571 is the FDA 510(k) clearance record for DEMAND FLOW VALVE & SONRA W/NASAL MASK, a class II device, cleared for Gale E. Dryden on under FDA product code CBN (Apparatus, Gas-Scavenging). FDA records list one 510(k) clearance for Gale E. Dryden. As of , FDA records show no recalls naming K854571.

Clearance record

Decision date
Received
(88 days to decision)
Product code
CBN Apparatus, Gas-Scavenging
Regulation
21 CFR 868.5430
Device class
Class II
Review panel
Anesthesiology
Applicant
Gale E. Dryden 5835 N. Tacoma Ave., Indianapolis IN
Third party review
No

Clearances, product code CBN

Trailing 12 months

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

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