Cala kIQ
FDA 510(k) clearance K222237 · decided 2022-11-22
Clearance details
- K-number
- K222237
- Device name
- Cala kIQ
- Applicant
- Cala Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-26
- Decision date
- 2022-11-22
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- QBC
- Device class
- 2
- Regulation number
- 882.5897
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cala Health
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cala kIQ Plus (K253587) | Cala Health, Inc. | 2026-03-17 |
| Encora X1 (K251517) | Encora, Inc. | 2026-02-05 |
| Felix NeuroAI System (K250096) | Fasikl Incorporated | 2025-07-01 |
| Cala kIQ (K243848) | Cala Health, Inc. | 2025-01-16 |
| Cala kIQ (K242259) | Cala Health, Inc. | 2024-11-22 |
| Cala Trio (K203288) | Cala Health, Inc. | 2021-10-05 |
| External upper limb tremor stimulator (K182706) | Cala Health, Inc. | 2018-10-25 |
| Cala ONE (DEN170028) | Cala Health, Inc. | 2018-04-26 |
Recalls involving this device
No recalls on record reference this clearance.