510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170089Unknown

Curve Positive Airway Pressure System

Fresca Medical, San Clemente CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN170089 is the FDA 510(k) clearance record for Curve Positive Airway Pressure System, a class II device, cleared for Fresca Medical on under FDA product code QBY (Positive Airway Pressure System). FDA's definition for product code QBY reads: "A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway...". FDA records list 2 510(k) clearances for Fresca Medical, from to . As of , FDA records show no recalls naming DEN170089.

Clearance record

Decision date
Received
(173 days to decision)
Product code
QBY Positive Airway Pressure System
Regulation
21 CFR 868.5273
Device class
Class II
Review panel
Anesthesiology
Applicant
Fresca Medical 1291 Puerta Del Sol Suite #200, San Clemente CA
Third party review
No

Clearances, product code QBY

Trailing 12 months

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

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