Paradigm System
510(k) K222291
Paradigm System is a Class II device made by Proprio, Inc., cleared under FDA 510(k) K222291 on 21 Apr 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222291 | Date21 Apr 2023 | StatusActive |
Official records
- FDA 510(k) database K222291
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K222291
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Paradigm 1100001 | 1100003 / 1100001 | 00850042604007 | — | No longer on the market |
| Paradigm 1100004 | 1100004 / 1100004 | 00850042604106 | — | On the market |
| Paradigm 1200001 | 1200001 / 1200001 | 00850042604090 | — | No longer on the market |
| Paradigm 1200002 | 1200002 / 1200002 | 00850042604045 | — | No longer on the market |
| Paradigm 1200003 | 1200003 / 1200003 | 00850042604052 | — | On the market |
| Paradigm 1200004 | 1200004 / 1200004 | 00850042604069 | — | On the market |
| Paradigm 1200005 | 1200005 / 1200005 | 00850042604076 | — | On the market |
| Paradigm 1200006 | 1200006 / 1200006 | 00850042604083 | — | On the market |
| Paradigm 1200007 | 1200007 / 1200007 | 00850042604038 | — | On the market |
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