Abbott Laboratories: FDA filings under this applicant name
FDA lists 889 510(k) clearances under the applicant name “Abbott Laboratories” (first 1976, latest 2026), plus 30 PMA decisions, across 282 product codes in 11 review panels. Median 510(k) review time under this name: 61 days. Since 2017 the median was 214 days, against 150 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 | 195 |
| 2013 | 3 | 186 |
| 2014 | 1 | 392 |
| 2015 | 7 | 112 |
| 2016 | 2 | 216 |
| 2017 | 6 | 262 |
| 2018 | 2 | 143 |
| 2019 | 1 | 32 |
| 2020 | 0 | — |
| 2021 | 1 | 192 |
| 2022 | 3 | 209 |
| 2023 | 7 | 90 |
| 2024 | 1 | 260 |
| 2025 | 3 | 239 |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abbott Laboratories took a median 214 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 67 | 67 |
| FPA | Set, Administration, Intravascular | 30 | 30 |
| GKZ | Counter, Differential Cell | 24 | 24 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 23 | 23 |
| CIG | Diazo Colorimetry, Bilirubin | 15 | 15 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 15 | 15 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 13 | 13 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 13 | 13 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 12 | 12 |
| NBW | System, Test, Blood Glucose, Over The Counter | 12 | 12 |
Plus 272 more product codes.
Review panels
- Clinical Chemistry (338)
- General Hospital (146)
- Clinical Toxicology (140)
- Microbiology (103)
- Gastroenterology and Urology (49)
- Immunology (46)
- Hematology (42)
- Cardiovascular (31)
- Anesthesiology (9)
- General and Plastic Surgery (9)
- Neurology (1)
Most recent Abbott Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252424 | Anti-HCV Next | MZO | 2026-04-28 | 270 |
| K243500 | ARCHITECT iGentamicin | LCD | 2025-07-09 | 239 |
| K243168 | Alinity i Rubella IgG | LFX | 2025-06-20 | 263 |
| K243283 | Alinity h-series System | GKZ | 2025-02-20 | 126 |
| K233932 | Alinity i Toxo IgM | LGD | 2024-08-30 | 260 |
| K232669 | TBI | QAT | 2023-09-29 | 28 |
| K222850 | HAVAb IgG II | LOL | 2023-08-10 | 323 |
| K220031 | Alinity h-series System | GKZ | 2023-08-04 | 576 |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | GJS | 2023-07-14 | 528 |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | DHA | 2023-06-05 | 63 |
879 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210003 | PMA | ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit | 2022-08-10 |
| P120008 | PMA | ABBOTT ARCHITECT AFP ASSAY | 2012-11-28 |
| P110029 | PMA | ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS | 2012-04-12 |
| P080023 | PMA | ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS | 2009-04-10 |
| P050020 | PMA | FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR | 2008-03-12 |
Recalls
267 product recalls in 165 recall events; 21 initiated in the last five years. Most recent: 2025-11-13.
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.
SEC filings
ABBOTT LABORATORIES (ABT): EDGAR filings, CIK 1800. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Abbott Laboratories (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- J1460 — Injection, gamma globulin, intramuscular, 1 cc (via DAH)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 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)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Laboratories?
FDA lists 889 510(k) clearances under the applicant name “Abbott Laboratories” (first 1976, latest 2026), plus 30 PMA decisions, across 282 product codes in 11 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 Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Laboratories is 61 days. Since 2017: 214 days, versus 150 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Abbott Laboratories?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 67); FPA (Set, Administration, Intravascular, 30); GKZ (Counter, Differential Cell, 24).
Next steps
- See all 889 Abbott Laboratories clearances with predicates and recalls
- Run predicate analysis for product code FRN, Abbott Laboratories'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.