St. Jude Medical Systems AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “St. Jude Medical Systems AB” (first 2011, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 68 |
| 2014 | 1 | 262 |
| 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | 2 |
| DXO | Transducer, Pressure, Catheter Tip | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent St. Jude Medical Systems AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | DXO | 2014-11-13 | 262 |
| K133587 | PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 | DRG | 2013-12-20 | 29 |
| K131452 | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 | DXO | 2013-09-05 | 108 |
| K111854 | AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER | DRG | 2011-10-21 | 114 |
| K110193 | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F | DXC | 2011-02-24 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named St. Jude Medical Systems AB.
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 St. Jude Medical Systems AB?
FDA lists 5 510(k) clearances under the applicant name “St. Jude Medical Systems AB” (first 2011, latest 2014), across 3 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 St. Jude Medical Systems AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name St. Jude Medical Systems AB is 108 days.
Which FDA product codes appear under St. Jude Medical Systems AB?
The most frequent FDA product codes under this applicant name are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 2); DXO (Transducer, Pressure, Catheter Tip, 2); DXC (Clamp, Vascular, 1).
Next steps
- See all 5 St. Jude Medical Systems AB clearances with predicates and recalls
- Run predicate analysis for product code DRG, St. Jude Medical Systems AB'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.