Data / Medical devices / United States / Curbell Medical Products, Inc.
Curbell Medical Products, Inc.: FDA-registered device maker in Orchard Park, NY, United States, 5 510(k) clearances
Curbell Medical Products, Inc. is registered with the FDA (registration 1320360) in Orchard Park, NY, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 2, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1320360
- FEI number
- 3000210521
- Address
- 20 Centre Dr, Orchard Park, NY, United States, 14127
- Owner or operator
- CURBELL MEDICAL PRODUCTS, INC. (9033808)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 11, 1998
- Registered through
- 2027
- Brand names listed
- BC201 Monitor, Bed Control, Classic, Clear Choice Lead Adapter, Clear Clip, Clear Tab/Snap Adapter, Clear tab/DIN Adapter, Click and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Communication, Powered | ILQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Environmental Control, Powered | IQA | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 2, 2023 | K222370 | SpO2 Extension Cable | DSA | Substantially Equivalent | Beijing Rongrui-Century Science & Technology Co., Ltd. | accessdata.fda.gov |
| November 7, 2018 | K182220 | Curbell branded Patient Monitoring Cables | DSA | Substantially Equivalent | Curbell Medical Products, Inc. | accessdata.fda.gov |
| July 15, 2011 | K103685 | PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA | DQA | Substantially Equivalent | Beijing Rongrui-Century Scie. & Tech. Co., Ltd. | accessdata.fda.gov |
| August 27, 2008 | K081762 | CURBELL PATIENT MONITORING CABLES | DSA | Substantially Equivalent | Curbell Electronics, Inc. | accessdata.fda.gov |
| May 5, 2008 | K080605 | SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL | DSA | Substantially Equivalent | Curbell Electronics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 5, 2014 | 68961 | Class II | Terminated | CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that | The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modificati | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of System, Communication, Powered
- All makers of System, Environmental Control, Powered
- All makers of Monitor, Bed Patient
- All makers of Oximeter
- All makers of Bed, Ac-Powered Adjustable Hospital
Updated April 2, 2023. 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.