510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140024Unknown

cNEP Airway

Sommetrics, San Diego CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140024 is the FDA 510(k) clearance record for cNEP Airway, a class II device, cleared for Sommetrics on under FDA product code PMB (External Airway). FDA's definition for product code PMB reads: "This device is intended to maintain airway patency using negative pressure during mild to moderate sedation". FDA records list one 510(k) clearance for Sommetrics. As of , FDA records show no recalls naming DEN140024.

Clearance record

Decision date
Received
(492 days to decision)
Product code
PMB External Airway
Regulation
21 CFR 868.5105
Device class
Class II
Review panel
Anesthesiology
Applicant
Sommetrics 16885 Via Del Campo, Suite 135, San Diego CA
Third party review
No

Clearances, product code PMB

Trailing 12 months

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

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