Pos-T-Vac, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Pos-T-Vac, Inc.” (first 1994, latest 2002), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 73 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | 11 | 11 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
Review panels
Most recent Pos-T-Vac, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020258 | SUPPORT SLEEVE | LKY | 2002-04-04 | 69 |
| K020154 | VT-1 | LKY | 2002-04-04 | 77 |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | LKY | 2001-11-09 | 88 |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | LKY | 2001-11-09 | 88 |
| K983246 | POS-T-VAC (IVP-600) | LKY | 1998-11-02 | 47 |
| K983245 | POS-T-VAC (AVP-1000) | LKY | 1998-11-02 | 47 |
| K981180 | REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT | LKY | 1998-08-28 | 149 |
| K981011 | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) | LKY | 1998-08-28 | 163 |
| K961309 | POS-T-VAC ID-300 | KZH | 1996-06-10 | 67 |
| K960828 | POS-T-VAC B-10 BAND KIT | LKY | 1996-03-08 | 8 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pos-T-Vac, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pos-T-Vac, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Pos-T-Vac, Inc.” (first 1994, latest 2002), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pos-T-Vac, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pos-T-Vac, Inc. is 73 days.
Which FDA product codes appear under Pos-T-Vac, Inc.?
The most frequent FDA product codes under this applicant name are LKY (Device, External Penile Rigidity, 11); KZH (Introducer, Syringe Needle, 1).
Next steps
- See all 12 Pos-T-Vac, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKY, Pos-T-Vac, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.