Data / Medical devices / United States / Event Medical, Ltd.
Event Medical, Ltd.: FDA-registered device maker in Lake Forest, CA, United States, 2 510(k) clearances
Event Medical, Ltd. is registered with the FDA (registration 3006135941) in Lake Forest, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 18, 2012. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006135941
- Address
- 60 Empire Dr, Lake Forest, CA, United States, 92630
- Owner or operator
- eVent Medical (9054964)
- Roles
- Manufacturer
- First device listed
- November 6, 2008
- Registered through
- 2026
- Brand names listed
- Inspiration, eVolution 3e
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 18, 2012 | K113743 | EVOLUTION 3E VENTILATOR | CBK | Substantially Equivalent | Event Medical, Inc. | accessdata.fda.gov |
| January 4, 2008 | K072590 | INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM | CBK | Substantially Equivalent | Event Medical, 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 |
|---|---|---|---|---|---|---|
| October 13, 2015 | 72491 | Class I | Terminated | Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. | A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. | accessdata.fda.gov |
| August 12, 2005 | 33276 | Not yet classified | Terminated | INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=S | Firm received reports of combustion within the blender system of the Inspiration Ventilator. | accessdata.fda.gov |
Compare with other makers
Updated November 19, 2015. 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.