# B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)

**Predicate Speed & CAPA Advisory Opportunity Score:** 67/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260302 |
| Device | B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC |
| Applicant | B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) |
| Specialty / panel | Microbiology |
| Product code | SJQ |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-30 |
| Decision date | 2026-10-23 |
| Review time (days) | 266 |
| Third-party review | No |
| Applicant location | Hennigsdorf, DE |

## Why this score
- A long 266-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 13 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260302). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.