Inneuroco, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Inneuroco, Inc.” (first 2016, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 137 days. Since 2017 the median was 146 days, against 90 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 |
|---|---|---|
| 2016 | 1 | 137 |
| 2017 | 2 | 124 |
| 2018 | 3 | 156 |
| 2019 | 1 | 169 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 175 |
| 2023 | 1 | 58 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inneuroco, Inc. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 5 | 5 |
| NRY | Catheter, Thrombus Retriever | 3 | 3 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- Cardiovascular (6)
- Neurology (3)
Most recent Inneuroco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232260 | Thinline Sheath Introducer | DYB | 2023-09-27 | 58 |
| K220331 | 091 Balloon Guide Catheter | DQY | 2022-07-29 | 175 |
| K190338 | 046 Zenith Flex | NRY | 2019-08-02 | 169 |
| K181354 | 074 Zenith Flex System | NRY | 2018-10-25 | 156 |
| K172167 | Zenith Flex System | NRY | 2018-04-19 | 275 |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | DQY | 2018-01-26 | 53 |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | DQY | 2017-12-06 | 113 |
| K171672 | 065 Zenith, 074 Zenith | DQY | 2017-10-19 | 135 |
| K161262 | Super Distal Access (SDA) | DQY | 2016-09-19 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Inneuroco, 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 Inneuroco, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Inneuroco, Inc.” (first 2016, latest 2023), across 3 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 Inneuroco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inneuroco, Inc. is 137 days. Since 2017: 146 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inneuroco, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 5); NRY (Catheter, Thrombus Retriever, 3); DYB (Introducer, Catheter, 1).
Next steps
- See all 9 Inneuroco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Inneuroco, 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.