510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180619Substantially Equivalent

Bongo

Innomed Healthscience, Inc., Deerfield Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180619 is the FDA 510(k) clearance record for Bongo, a class II device, cleared for Innomed Healthscience, Inc. on under FDA product code OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea). FDA's definition for product code OHP reads: "Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea". FDA records list one 510(k) clearance for Innomed Healthscience, Inc. As of , FDA records show no recalls naming K180619.

Clearance record

Decision date
Received
(160 days to decision)
Product code
OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Innomed Healthscience, Inc. 1701 W. Hillsboro Blvd., Suite 303, Deerfield Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHP

Trailing 12 months

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

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