Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pos-T-Vac, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
149 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020154 | VT-1 | Pos-T-Vac, Inc. | 2002-04-04 | 77 | 0 |
| K020258 | SUPPORT SLEEVE | Pos-T-Vac, Inc. | 2002-04-04 | 69 | 0 |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 | 88 | 0 |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 | 88 | 0 |
| K983245 | POS-T-VAC (AVP-1000) | Pos-T-Vac, Inc. | 1998-11-02 | 47 | 0 |
| K983246 | POS-T-VAC (IVP-600) | Pos-T-Vac, Inc. | 1998-11-02 | 47 | 0 |
| K981011 | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) | Pos-T-Vac, Inc. | 1998-08-28 | 163 | 0 |
| K981180 | REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS- | Pos-T-Vac, Inc. | 1998-08-28 | 149 | 0 |
| K961309 | POS-T-VAC ID-300 | Pos-T-Vac, Inc. | 1996-06-10 | 67 | 0 |
| K960828 | POS-T-VAC B-10 BAND KIT | Pos-T-Vac, Inc. | 1996-03-08 | 8 | 0 |
| K960342 | POS-T-VAC AVP-1000 & MVP-700 | Pos-T-Vac, Inc. | 1996-03-01 | 37 | 0 |
| K941087 | POS-T-VAC-AVP-1000 | Pos-T-Vac, Inc. | 1994-07-25 | 139 | 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