510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K002768Substantially Equivalent

Acapella

Dhd Healthcare Corp., Wampsville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002768 is the FDA 510(k) clearance record for ACAPELLA, a class II device, cleared for Dhd Healthcare Corp. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list 8 510(k) clearances for Dhd Healthcare Corp., from to . As of , FDA records show one recall naming K002768.

Clearance record

Decision date
Received
(90 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Dhd Healthcare Corp. One Madison St., Wampsville NY
510(k) summary
Summary
Third party review
No

Clearances, product code BWF

Trailing 12 months

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

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