Vidacare Corporation: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Vidacare Corporation” (first 2004, latest 2014), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 81 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Teleflex, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 80 |
| 2013 | 0 | — |
| 2014 | 3 | 113 |
| 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 14 | 14 |
| KNW | Instrument, Biopsy | 3 | 3 |
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| MOQ | Battery, Replacement, Rechargeable | 1 | 1 |
Review panels
Most recent Vidacare Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142377 | The OnControl Bone Marrow Biopsy System by Vidacare | KNW | 2014-12-17 | 113 |
| K141117 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM | FMI | 2014-07-08 | 69 |
| K132583 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM | FMI | 2014-02-11 | 179 |
| K120661 | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE | FMI | 2012-06-03 | 90 |
| K113872 | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE | KNW | 2012-03-08 | 69 |
| K101026 | POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO | FMI | 2010-07-27 | 105 |
| K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO | FMI | 2009-10-14 | 177 |
| K081713 | VERTEBRAL ACCESS SYSTEM BY VIDACARE | MOQ | 2008-11-21 | 157 |
| K072045 | ONCONTROL BONE MARROW BIOPSY SYSTEM | KNW | 2007-10-22 | 89 |
| K070759 | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM | FCF | 2007-05-21 | 62 |
11 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-05-12.
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.
Device clinical trials
An industry sponsor named Vidacare Corporation is the lead sponsor of 9 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02299102: A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers (Completed, started 2014-12)
- NCT01866475: Continuous Intraosseous Vascular Access Over 48 Hours (Completed, started 2014-11)
- NCT01866514: Proximal Humerus Site for Anesthesia (Completed, started 2013-05)
- NCT01866501: Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site (Completed, started 2013-05)
- NCT01853215: Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum (Completed, started 2013-04)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Vidacare Corporation (a text match, not an official crosswalk):
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via MOQ)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vidacare Corporation?
FDA lists 21 510(k) clearances under the applicant name “Vidacare Corporation” (first 2004, latest 2014), across 5 product codes in 3 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 Vidacare Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vidacare Corporation is 81 days.
Which FDA product codes appear under Vidacare Corporation?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 14); KNW (Instrument, Biopsy, 3); FCF (Instrument, Biopsy, Mechanical, Gastrointestinal, 2).
Next steps
- See all 21 Vidacare Corporation clearances with predicates and recalls
- Run predicate analysis for product code FMI, Vidacare Corporation'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.