Data / Medical devices / United States / SUNSET HEALTHCARE SOLUTIONS, Inc.
SUNSET HEALTHCARE SOLUTIONS, Inc.: FDA-registered device maker in Chicago, IL, United States, 12 510(k) clearances
SUNSET HEALTHCARE SOLUTIONS, Inc. is registered with the FDA (registration 3006446479) in Chicago, IL, United States. It lists 47 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 3, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006446479
- Address
- 141 W Jackson Blvd Ste 1950, Chicago, IL, United States, 60604
- Owner or operator
- Sunset Healthcare Solutions (9106379)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 10, 2008
- Registered through
- 2027
- Brand names listed
- Aerosol Mask, Bacteria Filter, CPAP Cleaning wipes, Christmas Tree Connector, Cough Assist, Disposable NIV Mask, Elbow Connector, FireSafe Cannula Valve and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Complaint file establishment | accessdata.fda.gov |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Brush, Cleaning, Tracheal Tube | EPE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Complaint file establishment | accessdata.fda.gov |
| Drain, Tee (Water Trap) | BYH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Flowmeter, Calibration, Gas | BXY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Complaint file establishment | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Complaint file establishment | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment | accessdata.fda.gov |
| Tube, Collection, Capillary Blood | GIO | 1 | Complaint file establishment | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Filter, Membrane | JRL | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| October 3, 2022 | K222376 | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) | FMK | Substantially Equivalent | Shandong Lianfa Medical Plastic Products Co. , Ltd. | accessdata.fda.gov |
| September 27, 2020 | K182906 | Portable Mesh Nebulizer | CAF | Substantially Equivalent | Feellife Health, Inc. | accessdata.fda.gov |
| March 24, 2016 | K151461 | Hybernite RT | BZE | Substantially Equivalent | Plastiflex Group NV | accessdata.fda.gov |
| April 24, 2014 | K132882 | ELECTRIC BREAST PUMP | HGX | Substantially Equivalent | Shantou Xinghe Electrical Apparatuses Co., Ltd. | accessdata.fda.gov |
| December 14, 2012 | K121955 | COUGHASSIST T70 DEVICE | NHJ | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 27, 2012 | K113544 | ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER | GZJ | Substantially Equivalent | Prospera Corporation | accessdata.fda.gov |
| September 13, 2011 | K102483 | SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 | CAH | Substantially Equivalent | Sunset Healthcare Solutions, LLC | accessdata.fda.gov |
| August 12, 2011 | K102120 | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 | CBK | Substantially Equivalent | Hsiner Co., Ltd. | accessdata.fda.gov |
| January 28, 2011 | K101136 | FISIO CHAMBER SPACE | NVP | Substantially Equivalent | Koo (Shanghai) Industries Co., Ltd. | accessdata.fda.gov |
| November 12, 2010 | K102626 | VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 | JCX | Substantially Equivalent | Vega Technologies, Inc. | accessdata.fda.gov |
| November 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| February 23, 2007 | K063268 | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 | BZD | Substantially Equivalent | Hsiner Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Flowmeter, Calibration, Gas
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Disinfector, Medical Devices
- All makers of Mask, Oxygen, Low Concentration, Venturi
- All makers of Support, Patient Position
Updated October 3, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.