Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultraspect , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
30 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103710 | WBR XPRESS PET | Ultraspect , Ltd. | 2011-01-19 | 30 | 0 |
| K091073 | WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION | Ultraspect , Ltd. | 2009-05-14 | 30 | 0 |
| K081201 | WBR XPRESS3.CARDIAC | Ultraspect , Ltd. | 2008-05-28 | 30 | 0 |
| K080784 | WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR X | Ultraspect , Ltd. | 2008-04-02 | 13 | 0 |
| K050815 | XACT.CARDIAC & XPRESS.CARDIAC | Ultraspect , Ltd. | 2005-04-26 | 26 | 0 |
| K040370 | WBR-FHR, WBR-FWB | Ultraspect , Ltd. | 2004-03-11 | 27 | 0 |
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