ABBOTT MEDICAL: FDA clearances and approvals
ABBOTT MEDICAL has 60 FDA 510(k) clearances (first 2019, latest 2026), plus 32 PMA decisions, across 46 product codes in 3 review panels. Median 510(k) review time: 86 days. Since 2017 its median was 86 days, against 107 days for all cleared 510(k)s in the same product codes. openFDA lists 43 product recalls by a recalling firm named ABBOTT MEDICAL.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 4 | 76 |
| 2020 | 4 | 90 |
| 2021 | 5 | 30 |
| 2022 | 8 | 115 |
| 2023 | 10 | 30 |
| 2024 | 8 | 43 |
| 2025 | 13 | 99 |
| 2026 | 8 | 100 |
Review time against the same product codes
Since 2017, ABBOTT MEDICAL's cleared 510(k)s took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 14 | 14 |
| DQY | Catheter, Percutaneous | 13 | 13 |
| DYB | Introducer, Catheter | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| MLV | Transcatheter Septal Occluder | 3 | 0 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 3 | 3 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 3 | 3 |
| DSQ | Ventricular (Assist) Bypass | 2 | 0 |
| GXD | Generator, Lesion, Radiofrequency | 2 | 2 |
Plus 36 more product codes.
Review panels
- Cardiovascular (82)
- Neurology (7)
- General and Plastic Surgery (3)
Most recent ABBOTT MEDICAL 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261729 | EnSite X EP System | DQK | 2026-09-17 | 114 |
| K262006 | EnSite X EP System | DQK | 2026-07-15 | 30 |
| K261631 | Amplatzer TorqVue Exchange System | DQY | 2026-06-17 | 30 |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | NQQ | 2026-04-24 | 199 |
| K260212 | EnSite X EP System | DQK | 2026-04-20 | 87 |
| K253907 | Disposable Radiofrequency Cannula | GXI | 2026-04-16 | 132 |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | DQY | 2026-03-13 | 28 |
| K252512 | Armada 14 NC PTA Catheter | LIT | 2026-02-13 | 186 |
| K253516 | Assert-IQ (DM5100) | MXD | 2025-12-18 | 36 |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | DQY | 2025-12-17 | 138 |
50 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250022 | PMA | Volt PFA System | 2025-12-19 |
| P240042 | PMA | Tendyne Transcatheter Mitral Valve System | 2025-05-23 |
| P230036 | PMA | Esprit BTK Everolimus Eluting Resorbable Scaffold System | 2024-04-26 |
| P230007 | PMA | TriClip G4 System | 2024-04-01 |
| P220013 | PMA | TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C | 2023-05-18 |
Recalls
43 product recalls in 16 recall events; 39 initiated in the last five years. Most recent: 2026-05-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of ABBOTT MEDICAL's product codes (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 does ABBOTT MEDICAL have?
ABBOTT MEDICAL has 60 FDA 510(k) clearances (first 2019, latest 2026), plus 32 PMA decisions, across 46 product codes in 3 review panels.
How long does FDA take to clear ABBOTT MEDICAL's 510(k)s?
The median time from FDA receipt to decision across ABBOTT MEDICAL's cleared 510(k)s is 86 days. Since 2017: 86 days, versus 107 days for all cleared 510(k)s in the same product codes.
What devices does ABBOTT MEDICAL make?
Its most frequent FDA product codes are DQK (Computer, Diagnostic, Programmable, 14); DQY (Catheter, Percutaneous, 13); DYB (Introducer, Catheter, 4).
Has ABBOTT MEDICAL had device recalls?
openFDA lists 43 product recalls in 16 recall events by a recalling firm whose name matches ABBOTT MEDICAL; the most recent began 2026-05-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 60 ABBOTT MEDICAL clearances with predicates and recalls
- Run predicate analysis for product code DQK, ABBOTT MEDICAL's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.