510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894734Substantially Equivalent

Rhinotherm Ultra 2

Twinmed Products, Inc., Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894734 is the FDA 510(k) clearance record for RHINOTHERM ULTRA 2, a class I device, cleared for Twinmed Products, Inc. on under FDA product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)). FDA records list one 510(k) clearance for Twinmed Products, Inc. As of , FDA records show no recalls naming K894734.

Clearance record

Decision date
Received
(207 days to decision)
Product code
KFZ Humidifier, Non-Direct Patient Interface (Home-Use)
Regulation
21 CFR 868.5460
Device class
Class I
Review panel
Anesthesiology
Applicant
Twinmed Products, Inc. 2601 Ocean Park Blvd., Santa Monica CA
Third party review
No

Clearances, product code KFZ

Trailing 12 months

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

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