Abbott: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Abbott” (first 2018, latest 2026), plus 1 PMA decision, across 8 product codes in 2 review panels. Median 510(k) review time under this name: 113 days. Since 2017 the median was 113 days, against 106 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 |
|---|---|---|
| 2018 | 2 | 27 |
| 2019 | 3 | 118 |
| 2020 | 0 | — |
| 2021 | 2 | 71 |
| 2022 | 2 | 118 |
| 2023 | 0 | — |
| 2024 | 1 | 197 |
| 2025 | 1 | 149 |
| 2026 | 2 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abbott took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 5 | 5 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 2 | 2 |
| DRA | Catheter, Steerable | 1 | 1 |
| DSQ | Ventricular (Assist) Bypass | 1 | 0 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 1 | 1 |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | 1 | 1 |
Review panels
- Cardiovascular (13)
- Clinical Chemistry (1)
Most recent Abbott 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | DQY | 2026-07-02 | 30 |
| K260993 | Amplatzer TorqVue Delivery System | DQY | 2026-04-24 | 29 |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | MXD | 2025-09-17 | 149 |
| K233655 | Lingo Glucose System | SAF | 2024-05-29 | 197 |
| K222297 | CentriMag Pre-connected Pack | DTZ | 2022-12-01 | 122 |
| K221213 | EnSite X EP System | DQK | 2022-08-18 | 113 |
| K212061 | EnSite X EP System | DQK | 2021-10-22 | 113 |
| K210392 | WorkMate Claris System | DQK | 2021-03-11 | 29 |
| K192593 | Confirm Rx Insertable Cardiac Monitor | MXC | 2019-10-18 | 28 |
| K190167 | MitraClip G4 Steerable Guide Catheter | DRA | 2019-05-29 | 118 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170038 | PMA | CentriMag Circulatory Support System | 2019-12-06 |
Recalls
19 product recalls in 13 recall events; 15 initiated in the last five years. Most recent: 2025-09-10.
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.
Device clinical trials
An industry sponsor named Abbott is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00513370: A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis (Completed, started 2007-09)
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 Spine, Inc. (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott?
FDA lists 13 510(k) clearances under the applicant name “Abbott” (first 2018, latest 2026), plus 1 PMA decision, across 8 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 Abbott?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott is 113 days. Since 2017: 113 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Abbott?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 5); DQY (Catheter, Percutaneous, 2); MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection), 2).
Next steps
- See all 13 Abbott clearances with predicates and recalls
- Run predicate analysis for product code DQK, Abbott'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.