Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hotspur Technologies — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
121 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130397 | ARROW GPSCATH BALLOON DILATATION CATHETER | Hotspur Technologies | 2013-06-20 | 121 | 0 |
| K113769 | GPSCATH BALLON DILATATION CATHETER | Hotspur Technologies | 2012-01-20 | 29 | 0 |
| K101047 | PTA-DUO PTA BALLOON CATHETER | Hotspur Technologies | 2010-07-13 | 90 | 0 |
| K100840 | EMBO PLUS EMBOLECTOMY CATHETER | Hotspur Technologies | 2010-07-12 | 110 | 0 |
| K100842 | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON | Hotspur Technologies | 2010-07-12 | 109 | 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