DEVILBISS SUCTION UNIT— 510(k) K982304
Substantially EquivalentSunrise Medical Hhg, Inc.
FDA 510(k) clearance K982304 for DEVILBISS SUCTION UNIT, Substantially Equivalent on 1998-09-25. Applicant: Sunrise Medical Hhg, Inc.. Device class: 2.
Clearance details
- Applicant
- Sunrise Medical Hhg, Inc.
- Product code
- Code JCX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, PA, US
Recent devices under product code JCX
view allMore clearances from Sunrise Medical Hhg, Inc.
view allAdverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K982304
K-number listed on FDA's recall record- Z-2246-2016 — DeVilbiss Model 7305P-D Powered Suction Unit
- Z-2319-2013 — DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982304.
Data sourced from openFDA. This site is unofficial and independent of the FDA.