Access Vascular, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Access Vascular, Inc.” (first 2018, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. Since 2017 the median was 122 days, against 143 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 152 |
| 2019 | 0 | — |
| 2020 | 1 | 114 |
| 2021 | 1 | 122 |
| 2022 | 2 | 222 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 4 | 80 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Access Vascular, Inc. took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 6 | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 3 |
Review panels
- General Hospital (9)
Most recent Access Vascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | LJS | 2025-08-01 | 266 |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | LJS | 2025-07-01 | 74 |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | FOZ | 2025-03-27 | 86 |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | LJS | 2025-01-17 | 28 |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | FOZ | 2022-12-07 | 266 |
| K213550 | HydroPICC 5F Dual Lumen Catheter | LJS | 2022-05-04 | 177 |
| K203069 | HydroMID | FOZ | 2021-02-08 | 122 |
| K193015 | HydroPICC (PICC-142) | LJS | 2020-02-20 | 114 |
| K172885 | HydroPICC | LJS | 2018-02-20 | 152 |
Recalls
9 product recalls in 6 recall events; 8 initiated in the last five years. Most recent: 2023-08-31.
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 Access Vascular, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04911842: Midline Failures: A Comparison Between a Hydrophilic Biomaterial and Thermoplastic Polyurethane (Completed, started 2021-05-20)
- NCT04656548: A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line (Completed, started 2020-11-13)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Access Scientific, Inc. (14 510(k)s)
- Access Surgical Intl., Inc. (9 510(k)s)
- Access Bio Incorporate (4 510(k)s)
- Access / God Loves You (4 510(k)s)
- Access Point Medical, LLC (4 510(k)s)
- Access Bio, Inc. (3 510(k)s)
- Access Devices, Inc. (3 510(k)s)
- Access Battery, Inc. (2 510(k)s)
- Access Cardiosystems, Inc. (2 510(k)s)
- Access Pharmaceuticals, Inc. (2 510(k)s)
- Access Radiology Corp. (2 510(k)s)
- Access Point Technologies Ep, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Access Vascular, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Access Vascular, Inc.” (first 2018, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Access Vascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Access Vascular, Inc. is 122 days. Since 2017: 122 days, versus 143 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Access Vascular, Inc.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 6); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 3).
Next steps
- See all 9 Access Vascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Access Vascular, 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.