510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092611Substantially Equivalent

Sonarmed Airway Monitoring System, Model 0901

Sonarmed, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092611 is the FDA 510(k) clearance record for SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901, a class II device, cleared for Sonarmed, Inc. on under FDA product code OQU (Airway Monitoring System). FDA's definition for product code OQU reads: "The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip". FDA records list 3 510(k) clearances for Sonarmed, Inc., from to . As of , FDA records show no recalls naming K092611.

Clearance record

Decision date
Received
(245 days to decision)
Product code
OQU Airway Monitoring System
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Sonarmed, Inc. 5513 W. 74th St., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQU

Trailing 12 months

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

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