St Jude Medical: FDA filings under this applicant name
FDA lists 128 510(k) clearances under the applicant name “St Jude Medical” (first 1989, latest 2018), plus 11 PMA decisions, across 34 product codes in 3 review panels. Median 510(k) review time under this name: 65 days. Since 2017 the median was 258 days, against 115 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 |
|---|---|---|
| 2012 | 7 | 30 |
| 2013 | 8 | 88 |
| 2014 | 9 | 127 |
| 2015 | 4 | 28 |
| 2016 | 11 | 254 |
| 2017 | 2 | 164 |
| 2018 | 3 | 258 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 St Jude Medical took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 26 | 26 |
| DQK | Computer, Diagnostic, Programmable | 23 | 23 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 14 | 14 |
| DQY | Catheter, Percutaneous | 13 | 13 |
| KRH | Ring, Annuloplasty | 10 | 10 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 6 | 6 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 3 | 3 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
Plus 24 more product codes.
Review panels
- Cardiovascular (130)
- Neurology (6)
- Radiology (3)
Most recent St Jude Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181382 | GuardianTM Burr Hole Cover System | GXR | 2018-07-20 | 56 |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2 | DQK | 2018-04-23 | 258 |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | MTD | 2018-04-23 | 258 |
| K173232 | myMerlin(TM) Mobile Application Model APP1001 | MXC | 2017-11-02 | 29 |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | MXC | 2017-09-29 | 298 |
| K162643 | MediGuide Technology System | DQK | 2016-12-13 | 82 |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D | DRF | 2016-12-13 | 309 |
| K160218 | AutoMark Module | DQK | 2016-12-13 | 319 |
| K160210 | EnSite Precision Cardiac Mapping System v2.0 | DQK | 2016-12-13 | 320 |
| K161873 | Pacel Flow Directed Pacing Catheter | LDF | 2016-11-22 | 138 |
118 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130026 | PMA | TACTICATH QUARTZ SET | 2014-10-24 |
| P020035 | PMA | X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM | 2003-09-30 |
| P020052 | PMA | RESPONSE CV CATHETER SYSTEM | 2003-05-07 |
| P960016 | PMA | LIVEWIRE(R) CARDIAC ABLATION SYSTEM | 1999-05-04 |
| P970030 | PMA | TORONTO SPV VALVE | 1997-11-04 |
Recalls
97 product recalls in 43 recall events; 13 initiated in the last five years. Most recent: 2025-02-03.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under St Jude Medical (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under St Jude Medical?
FDA lists 128 510(k) clearances under the applicant name “St Jude Medical” (first 1989, latest 2018), plus 11 PMA decisions, across 34 product codes in 3 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 St Jude Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name St Jude Medical is 65 days. Since 2017: 258 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under St Jude Medical?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 26); DQK (Computer, Diagnostic, Programmable, 23); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 14).
Next steps
- See all 128 St Jude Medical clearances with predicates and recalls
- Run predicate analysis for product code DYB, 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.