DeviceSignal · 510(k) cleared
S.M.A.I.O
FDA 510(k) decision recorded 2026-08-17 · K261500 · Traditional 510(k)
Event510(k) cleared
Effective2026-08-17
DecisionSESE
On 2026-08-17 the FDA recorded a 510(k) clearance decision for S.M.A.I.O, for KBA3D (v2.4.0). Clearance K261500. Product code LLZ. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K261500
- Applicant
- S.M.A.I.O
- Device
- KBA3D (v2.4.0)
- Decided on
- 2026-08-17
- Received on
- 2026-05-06
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- LLZ
- Review days
- 103
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K261500- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
06fdba6162d84fe8ea8cb208a09e5fba8352e44d3ae86faa526d0ff0c1a0f0aa- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)