CenterPoint Systems, LLC: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “CenterPoint Systems, LLC” (first 2019, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 65 days. Since 2017 the median was 65 days, against 96 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 |
|---|---|---|
| 2019 | 1 | 121 |
| 2020 | 0 | — |
| 2021 | 1 | 324 |
| 2022 | 0 | — |
| 2023 | 2 | 166 |
| 2024 | 4 | 72 |
| 2025 | 4 | 109 |
| 2026 | 5 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CenterPoint Systems, LLC took a median 65 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 9 | 9 |
| DYB | Introducer, Catheter | 6 | 6 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
Review panels
Most recent CenterPoint Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262240 | SSPC NXT Delivery Catheter | DQY | 2026-07-29 | 28 |
| K261766 | CPS Locator 3D Plus Delivery Catheter | DQY | 2026-07-29 | 62 |
| K261492 | FieldFlex Steerable Sheath | DYB | 2026-06-05 | 30 |
| K260942 | AuST Steerable Sheath | DYB | 2026-04-07 | 18 |
| K260163 | AuST CSP Introducer | DYB | 2026-02-19 | 30 |
| K250147 | CPS Locator 3D Delivery Catheter | DQY | 2025-08-22 | 213 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | DQY | 2025-06-27 | 100 |
| K250492 | FlexiGo 3D Delivery Catheter | DQY | 2025-06-18 | 118 |
| K251051 | AuST Steerable Sheath | DYB | 2025-04-30 | 27 |
| K243180 | SSPC NXT Delivery Catheter | DQY | 2024-12-04 | 65 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named CenterPoint Systems, LLC.
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 CenterPoint Systems, LLC?
FDA lists 17 510(k) clearances under the applicant name “CenterPoint Systems, LLC” (first 2019, latest 2026), across 4 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 CenterPoint Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name CenterPoint Systems, LLC is 65 days. Since 2017: 65 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CenterPoint Systems, LLC?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 9); DYB (Introducer, Catheter, 6); FBN (Choledochoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 17 CenterPoint Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code DQY, CenterPoint Systems, LLC'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.