Acumen Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Acumen Medical, Inc.” (first 2004, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 9 | 9 |
| DQY | Catheter, Percutaneous | 3 | 3 |
Review panels
- Cardiovascular (12)
Most recent Acumen Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083855 | MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 | DYB | 2009-02-17 | 55 |
| K080500 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 | DYB | 2008-03-13 | 17 |
| K070396 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 | DYB | 2007-05-22 | 99 |
| K070051 | ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM | DQY | 2007-04-06 | 92 |
| K070197 | ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY | DYB | 2007-02-23 | 32 |
| K062145 | MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 | DYB | 2006-08-23 | 27 |
| K062084 | 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 | DQY | 2006-08-18 | 28 |
| K053400 | ACUMEN SINGLE-LUMEN DELIVERY SHEATH | DYB | 2006-06-19 | 195 |
| K051515 | MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 | DYB | 2005-09-01 | 85 |
| K050015 | MODIFIED ACUMEN SHEATH, MODEL TTWO767 | DYB | 2005-02-03 | 30 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acumen Medical, 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 Acumen Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Acumen Medical, Inc.” (first 2004, latest 2009), 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 Acumen Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acumen Medical, Inc. is 55 days.
Which FDA product codes appear under Acumen Medical, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 9); DQY (Catheter, Percutaneous, 3).
Next steps
- See all 12 Acumen Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Acumen Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.