Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Angiolaz, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
164 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994362 | HEADLAMP HL2000. | Angiolaz, Inc. | 2000-05-11 | 136 | 0 |
| K992447 | 50 W METAL HALIDE ILLUMINATOR, VES 0501. | Angiolaz, Inc. | 1999-10-20 | 90 | 0 |
| K982397 | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM | Angiolaz, Inc. | 1998-09-10 | 63 | 0 |
| K982409 | VES 1501-M | Angiolaz, Inc. | 1998-08-21 | 42 | 0 |
| K981819 | ANGIOLAZ VES-1CAM | Angiolaz, Inc. | 1998-08-04 | 74 | 0 |
| K981821 | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | Angiolaz, Inc. | 1998-07-29 | 68 | 0 |
| K981827 | VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM | Angiolaz, Inc. | 1998-07-28 | 67 | 0 |
| K933868 | ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORI | Angiolaz, Inc. | 1993-11-10 | 96 | 0 |
| K913129 | ANGIOLAZ ANGIOSCOPE CATHETER | Angiolaz, Inc. | 1991-12-27 | 164 | 0 |
| K902329 | ULTRA-VU ANGIOSCOPE | Angiolaz, Inc. | 1990-08-22 | 90 | 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