Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vascular Control Systems, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
246 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060573 | BURBANK TENACULUM | Vascular Control Systems, Inc. | 2006-04-21 | 46 | 0 |
| K052209 | VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 | Vascular Control Systems, Inc. | 2005-09-06 | 22 | 0 |
| K032125 | CSTAT, MODELS 09-0014-01 AND 09-0014-02 | Vascular Control Systems, Inc. | 2004-02-09 | 214 | 0 |
| K031812 | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, | Vascular Control Systems, Inc. | 2003-12-12 | 183 | 0 |
| K031358 | TRANSVAGINAL DOPPLER PROBE | Vascular Control Systems, Inc. | 2003-05-09 | 9 | 0 |
| K030078 | BURBANK TENACULUM, MODEL 09-0011-01 | Vascular Control Systems, Inc. | 2003-01-24 | 15 | 0 |
| K023154 | VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 | Vascular Control Systems, Inc. | 2002-12-20 | 88 | 0 |
| K023024 | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 | Vascular Control Systems, Inc. | 2002-09-26 | 15 | 0 |
| K011863 | VCS-A SERIES CLAMP | Vascular Control Systems, Inc. | 2002-02-15 | 246 | 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