510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002153Substantially Equivalent

Ultrasonic Nebulizer, Model Ne-520

Medisana USA Corp., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002153 is the FDA 510(k) clearance record for ULTRASONIC NEBULIZER, MODEL NE-520, a class II device, cleared for Medisana USA, Inc. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Medisana USA, Inc. As of , FDA records show no recalls naming K002153.

Clearance record

Decision date
Received
(239 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Medisana USA, Inc. 11820 Red Hibiscus Dr., Bonita Springs FL
510(k) summary
Statement
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260