Access Scientific, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Access Scientific, Inc.” (first 2008, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 97 days. Since 2017 the median was 104 days, against 88 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 |
|---|---|---|
| 2012 | 1 | 43 |
| 2013 | 2 | 82 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 90 |
| 2017 | 0 | — |
| 2018 | 2 | 66 |
| 2019 | 1 | 262 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Access Scientific, Inc. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 13 | 13 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
- Cardiovascular (14)
Most recent Access Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model | DYB | 2019-07-25 | 262 |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | DQY | 2018-09-26 | 104 |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | DYB | 2018-09-18 | 29 |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | DYB | 2016-11-17 | 90 |
| K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | DYB | 2013-09-04 | 134 |
| K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | 2013-06-07 | 31 |
| K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | DYB | 2012-07-27 | 43 |
| K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | 2011-07-15 | 56 |
| K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER | DYB | 2011-06-22 | 61 |
| K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | 2011-03-22 | 306 |
4 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2020-06-15.
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.
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 Surgical Intl., Inc. (9 510(k)s)
- Access Vascular, 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 Scientific, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Access Scientific, Inc.” (first 2008, latest 2019), 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 Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Access Scientific, Inc. is 97 days. Since 2017: 104 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Access Scientific, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 13); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 14 Access Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Access Scientific, 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.