510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K960397Substantially Equivalent

Medicator Aerosol Drug Delivery System

Healthline Medical, Baldwin Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960397 is the FDA 510(k) clearance record for MEDICATOR AEROSOL DRUG DELIVERY SYSTEM, a class II device, cleared for Healthline Medical on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Healthline Medical. As of , FDA records show no recalls naming K960397.

Clearance record

Decision date
Received
(88 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Healthline Medical 4610 Littlejohn St., Baldwin Park CA
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