Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultraguide , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
77 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023227 | USG 2000SA | Ultraguide , Ltd. | 2002-10-22 | 25 | 0 |
| K022354 | ULTRAGUIDE CTG 2000SA | Ultraguide , Ltd. | 2002-08-13 | 25 | 0 |
| K013150 | MR-GUIDE 2000 | Ultraguide , Ltd. | 2001-10-18 | 28 | 0 |
| K011418 | ULTRAGUIDE MR-GUIDE 3000 | Ultraguide , Ltd. | 2001-05-24 | 15 | 0 |
| K002258 | ULTRAGUIDE CT-GUIDE 1010 | Ultraguide , Ltd. | 2000-08-08 | 14 | 0 |
| K974432 | ULTRAGUIDE 1000 | Ultraguide , Ltd. | 1998-02-09 | 77 | 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