Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spd Swiss Precision Diagnostics GmbH — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240025 | Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2024-01-31 | 28 | 0 |
| K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-09-21 | 343 | 0 |
| K210341 | One Step Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-03-10 | 398 | 0 |
| K200913 | Clearblue® Early Digital Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2021-08-13 | 494 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda