Abbott (St. Jude Medical): FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Abbott (St. Jude Medical)” (first 2019, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 61 days. Since 2017 the median was 61 days, against 104 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.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 58 |
| 2020 | 4 | 70 |
| 2021 | 1 | 29 |
| 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 Abbott (St. Jude Medical) took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 5 | 5 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Abbott (St. Jude Medical) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212206 | Jot Dx Insertable Cardiac Monitor | MXC | 2021-08-13 | 29 |
| K202876 | Confirm Rx Insertable Cardiac Monitor | MXC | 2020-12-01 | 64 |
| K202888 | Confirm Rx Insertable Cardiac Monitor | MXC | 2020-11-23 | 56 |
| K200721 | Agilis HisPro Steerable Catheter With Electrodes | DQY | 2020-06-03 | 76 |
| K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | MXC | 2020-03-17 | 109 |
| K190295 | Confirm Rx Insertable Cardiac Monitor | MXC | 2019-04-10 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Abbott (St. Jude Medical).
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.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Vascular (50 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Molecular, Inc. (18 510(k)s)
- Abbott Mfg., Inc. (14 510(k)s)
- Abbott Medical Optics, Inc. (13 510(k)s)
- Abbott (13 510(k)s)
- Abbott Spine, Inc. (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott (St. Jude Medical)?
FDA lists 6 510(k) clearances under the applicant name “Abbott (St. Jude Medical)” (first 2019, latest 2021), 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 Abbott (St. Jude Medical)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott (St. Jude Medical) is 61 days. Since 2017: 61 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Abbott (St. Jude Medical)?
The most frequent FDA product codes under this applicant name are MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection), 5); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 6 Abbott (St. Jude Medical) clearances with predicates and recalls
- Run predicate analysis for product code MXC, Abbott (St. Jude Medical)'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.