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
K982304Substantially Equivalent

Devilbiss Suction Unit

Sunrise Medical Hhg, Inc., Somerset PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982304 is the FDA 510(k) clearance record for DEVILBISS SUCTION UNIT, a class II device, cleared for Sunrise Medical Hhg, Inc. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 10 510(k) clearances for Sunrise Medical Hhg, Inc., from to . As of , FDA records show 3 recalls naming K982304.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sunrise Medical Hhg, Inc. 100 Devilbiss Dr., Somerset PA
510(k) summary
Summary
Third party review
No

Clearances, product code JCX

Trailing 12 months
1 clearance under product code JCX in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260