510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K072163Substantially Equivalent

Happyneb II, Happyneb III, Speedy, Nebby Plus and Myneb, Model 5

3A Health Care S.r.l., North Reading MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072163 is the FDA 510(k) clearance record for HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5, a class II device, cleared for 3A Health Care S.R.L. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for 3A Health Care S.R.L. As of , FDA records show no recalls naming K072163.

Clearance record

Decision date
Received
(213 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
3A Health Care S.R.L. 5 Timber Ln., North Reading MA
510(k) summary
Summary PDF
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