Paradigm 1200014
by Proprio
Paradigm 1200014 is a Class II device made by Proprio, cleared under FDA 510(k) K252950 on 15 Dec 2025 (2 earlier submissions) and listed in FDA GUDID since 21 Mar 2025 (UDI-DI 00850042604175), 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 | NumberK252950 | Date15 Dec 2025 | StatusActive |
| United States | GUDID listing | Number00850042604175 | Date21 Mar 2025 | StatusListed |
Official records
- AccessGUDID record 00850042604175
- FDA 510(k) database K252950
- FDA 510(k) database K250879
- FDA 510(k) database K243258
Across registries
- FDA 510(k) K252950 decided 15 Dec 2025 Active
- FDA GUDID UDI-DI 00850042604175 listed 21 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K243258
- Listed FDA GUDID 00850042604175
- Cleared FDA 510(k) K250879
- Cleared FDA 510(k) K252950
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Paradigm
- Generic name
- Optical surgical tracking system spatial marker, reusable
- Model / Ref / Catalog
- 1200014
- Primary DI / UDI-DI
- 00850042604175
- FDA product code
- OLO
- GMDN term
- Optical surgical tracking system spatial marker, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
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