AbbVie , Inc.: FDA clearances and approvals
AbbVie , Inc. has 7 FDA 510(k) clearances (first 2014, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 110 days. openFDA lists 4 product recalls by a recalling firm named AbbVie , Inc. It is the industry lead sponsor of 28 device clinical trials on ClinicalTrials.gov. It files with the SEC as AbbVie Inc. (ABBV).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 3 | 262 |
| 2015 | 3 | 110 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 28 |
Review time against the same product codes
Since 2017, AbbVie , Inc.'s cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 6 | 6 |
| LCJ | Tissue Expander And Accessories | 1 | 1 |
Review panels
Most recent AbbVie , Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | LCJ | 2026-01-16 | 28 |
| K142816 | AbbVie J | KNT | 2015-01-14 | 107 |
| K142793 | AbbVie PEG | KNT | 2015-01-14 | 110 |
| K142792 | AbbVie NJ | KNT | 2015-01-14 | 110 |
| K133129 | ABBVIE NJ | KNT | 2014-06-19 | 262 |
| K133087 | ABBVIE PEG | KNT | 2014-06-19 | 262 |
| K133096 | ABB VIE J | KNT | 2014-06-18 | 261 |
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2017-04-27.
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.
Device clinical trials
AbbVie , Inc. is the industry lead sponsor of 28 device studies on ClinicalTrials.gov (9 active or recruiting). Most recent:
- NCT07207369: A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars (Recruiting, started 2025-10-24)
- NCT07186595: A Study to Evaluate the Safety and Effectiveness of JUVÉDERM Products in Adult Participants for the Change of Their Overall Facial Appearance (Active not recruiting, started 2025-09-25)
- NCT07122583: A Study to Assess Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System (Active not recruiting, started 2025-07-22)
- NCT07032597: A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants (Active not recruiting, started 2025-05-26)
- NCT06822738: A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma (Recruiting, started 2025-02-11)
SEC filings
AbbVie Inc. (ABBV): EDGAR filings, CIK 1551152. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does AbbVie , Inc. have?
AbbVie , Inc. has 7 FDA 510(k) clearances (first 2014, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear AbbVie , Inc.'s 510(k)s?
The median time from FDA receipt to decision across AbbVie , Inc.'s cleared 510(k)s is 110 days.
What devices does AbbVie , Inc. make?
Its most frequent FDA product codes are KNT (Tubes, Gastrointestinal (And Accessories), 6); LCJ (Tissue Expander And Accessories, 1).
Has AbbVie , Inc. had device recalls?
openFDA lists 4 product recalls in 2 recall events by a recalling firm whose name matches AbbVie , Inc; the most recent began 2017-04-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 AbbVie , Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, AbbVie , Inc.'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.