Data / Medical devices / United States / Sleepres, Inc
Sleepres, Inc: FDA-registered device maker in Fremont, CA, United States, 1 510(k) clearance
Sleepres, Inc is registered with the FDA (registration 3022949799) in Fremont, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022949799
- Address
- 47987 Fremont Blvd, Fremont, CA, United States, 94538
- Owner or operator
- SleepRes, Inc. (10085259)
- Roles
- Specification developer
- First device listed
- May 25, 2022
- Registered through
- 2027
- Brand names listed
- Kricket (SleepRes PAP System), Vcom
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Connector, Airway (Extension) | BZA | 1 | Specification developer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 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 |
|---|---|---|---|---|---|---|
| December 15, 2025 | K251770 | SleepRes PAP System | BZD | Substantially Equivalent | Sleepres, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 15, 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.