Data / Medical devices / United States / Intego Software, LLC D/B/A Critical Alert
Intego Software, LLC D/B/A Critical Alert: FDA-registered device maker in Jacksonville, FL, United States, 2 510(k) clearances
Intego Software, LLC D/B/A Critical Alert is registered with the FDA (registration 3015437214) in Jacksonville, FL, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015437214
- Address
- 8301 Cypress Plaza Dr Ste 109, Jacksonville, FL, United States, 32256
- Owner or operator
- Intego Software, LLC d/b/a Critical Alert (10060139)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 6, 2019
- Registered through
- 2026
- Brand names listed
- CommonPath, CommonPath Enterprise, TigerConnect Alarm Management
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Infusion Safety Management Software | PHC | 2 | Manufacturer | accessdata.fda.gov |
| System, Communication, Powered | ILQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 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 |
|---|---|---|---|---|---|---|
| September 30, 2025 | K243270 | TigerConnect Alarm Management | MSX | Substantially Equivalent | Tigerconnect | accessdata.fda.gov |
| May 11, 2020 | K193043 | Critical Alert CommonPath Enterprise | MSX | Substantially Equivalent | Critical Alert | accessdata.fda.gov |
Compare with other makers
- All makers of Infusion Safety Management Software
- All makers of System, Network And Communication, Physiological Monitors
- All makers of System, Communication, Powered
Updated September 30, 2025. 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.