Data / Medical devices / United States / Spiracle Technology
Spiracle Technology: FDA-registered device maker in Los Alamitos, CA, United States, 6 510(k) clearances
Spiracle Technology is registered with the FDA (registration 2030745) in Los Alamitos, CA, United States. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 17, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2030745
- FEI number
- 3000204983
- Address
- 10601 Calle Lee Ste 190, Los Alamitos, CA, United States, 90720
- Owner or operator
- SPIRACLE TECHNOLOGY (9026347)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 6, 1996
- Registered through
- 2026
- Brand names listed
- 302 OX Inhaltor, BravO2 Regulator, CPR MASK FERNO2, FERNO2, Gaseous Oxygen Supply Valve, HFOC, MVP, ORO2 FLOW CONTROL VALVE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Specification developer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Specification developer | accessdata.fda.gov |
| Flowmeter, Calibration, Gas | BXY | 1 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Specification developer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Specification developer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 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 |
|---|---|---|---|---|---|---|
| November 17, 2017 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) | CBP | Substantially Equivalent | Xiamen Compower Medical Tech. Co., Ltd. | accessdata.fda.gov |
| August 13, 2007 | K070371 | FINGERTIP PULSE OXIMETER MD300C | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| January 13, 2005 | K043286 | ANEROID SPHYGMOMANOMETER, MODEL BK2002 | DXQ | Substantially Equivalent | Wenzhou Bokang Instrument Co.,Ltd | accessdata.fda.gov |
| February 6, 2004 | K031434 | BAWMED E-Z BAG RESUSCITATOR | BTM | Substantially Equivalent | Bawmed UK | accessdata.fda.gov |
| April 8, 1997 | K963755 | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR | CBP | Substantially Equivalent | Spiracle Technology | accessdata.fda.gov |
| February 29, 1996 | K953349 | SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE | CBP | Substantially Equivalent | Spiracle Technology | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Valve, Non-Rebreathing
- All makers of Laryngoscope, Rigid
- All makers of Ventilator, Emergency, Manual (Resuscitator)
- All makers of Flowmeter, Calibration, Gas
Updated November 17, 2017. 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.