Data / Medical devices / United States / Oricare Inc.
Oricare Inc.: FDA-registered device maker in Quakertown, PA, United States, 4 510(k) clearances
Oricare Inc. is registered with the FDA (registration 3009129579) in Quakertown, PA, United States. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 9, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009129579
- Address
- 1900 Am Dr, Quakertown, PA, United States, 18951
- Owner or operator
- Oricare Inc. (10036506)
- Roles
- Specification developer
- First device listed
- May 12, 2011
- Registered through
- 2026
- Brand names listed
- A9800 Anesthesia Workstation, C4500 Medical Compressor, L2700 Surgical Lights, LuvRes F1NV, LuvRes F2NV, T3600 Surgical Table, V8800 Critical Care Ventilator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Specification developer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Specification developer | accessdata.fda.gov |
| Gas-Machine, Anesthesia | BSZ | 2 | Specification developer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Specification developer | accessdata.fda.gov |
| Light, Surgical, Ceiling Mounted | FSY | 2 | Specification developer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Specification developer | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 1 | Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | 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 |
|---|---|---|---|---|---|---|
| May 9, 2014 | K131790 | A9800 ANESTHESIA WORKSTATION | BSZ | Substantially Equivalent | Oricare, Inc. | accessdata.fda.gov |
| June 6, 2013 | K120931 | CRITICAL CARE VENTILATOR | CBK | Substantially Equivalent | Oricare, Inc. | accessdata.fda.gov |
| December 18, 2012 | K122875 | ORICARE L2700 | FSY | Substantially Equivalent | Oricare, Inc. | accessdata.fda.gov |
| August 10, 2012 | K113338 | MEDICAL AIR COMPRESSOR | BTI | Substantially Equivalent | Oricare, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Table, Operating-Room, Electrical
- All makers of Compressor, Air, Portable
- All makers of Gas-Machine, Anesthesia
- All makers of Mask, Oxygen
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Updated May 9, 2014. 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.