Abbott Diabetes Care, Inc.: FDA clearances and approvals
Abbott Diabetes Care, Inc. has 39 FDA 510(k) clearances (first 2000, latest 2024), plus 2 PMA and 1 De Novo decisions, across 10 product codes in 1 review panel. Median 510(k) review time: 164 days. Since 2017 its median was 178 days, against 190 days for all cleared 510(k)s in the same product codes. openFDA lists 57 product recalls by a recalling firm named Abbott Diabetes Care, Inc. It is the industry lead sponsor of 35 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 31 |
| 2013 | 2 | 151 |
| 2014 | 1 | 228 |
| 2015 | 1 | 356 |
| 2016 | 1 | 92 |
| 2017 | 1 | 91 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 190 |
| 2021 | 3 | 237 |
| 2022 | 2 | 240 |
| 2023 | 3 | 150 |
| 2024 | 2 | 178 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Abbott Diabetes Care, Inc.'s cleared 510(k)s took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 19 | 19 |
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | 7 | 7 |
| LFR | Glucose Dehydrogenase, Glucose | 5 | 5 |
| LZG | Pump, Infusion, Insulin | 3 | 3 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | 3 | 3 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | 1 |
| MDS | Sensor, Glucose, Invasive | 1 | 0 |
| PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | 1 | 0 |
| SBH | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | 1 | 1 |
| SJD | Integrated Continuous Glucose Ketone Monitoring System | 1 | 0 |
Review panels
- Clinical Chemistry (42)
Most recent Abbott Diabetes Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233861 | Libre Rio Continuous Glucose Monitoring System | SBH | 2024-06-07 | 184 |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | QBJ | 2024-04-23 | 172 |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | QBJ | 2023-04-13 | 150 |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | QBJ | 2023-03-03 | 200 |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | QLG | 2023-02-21 | 90 |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | QLG | 2022-05-26 | 157 |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | QLG | 2022-05-26 | 322 |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | QLG | 2021-11-22 | 237 |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | QLG | 2021-08-11 | 120 |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | QLG | 2021-07-30 | 396 |
29 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250049 | De Novo | Integrated Continuous Glucose Ketone Monitoring System | 2026-08-25 |
| P160030 | PMA | Freestyle Libre Flash Glucose Monitoring System | 2017-09-27 |
| P150021 | PMA | FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM | 2016-09-23 |
Recalls
57 product recalls in 21 recall events; 10 initiated in the last five years. Most recent: 2025-11-24.
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
Abbott Diabetes Care, Inc. is the industry lead sponsor of 35 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT06921902: Glycemic Metrics and Patterns in People With and Without Prediabetes (Recruiting, started 2025-02-28)
- NCT06668935: Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring (Recruiting, started 2024-10-24)
- NCT06268808: Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy (Completed, started 2024-07-19)
- NCT05944432: CGM Use in Adults With Type 2 Diabetes on Basal Insulin (Active not recruiting, started 2023-07-14)
- NCT05251116: Study of an Interstitial Fluid Glucose Sensor (Completed, started 2021-12-11)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Abbott Diabetes Care, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZG)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZG)
Frequently asked questions
How many FDA 510(k) clearances does Abbott Diabetes Care, Inc. have?
Abbott Diabetes Care, Inc. has 39 FDA 510(k) clearances (first 2000, latest 2024), plus 2 PMA and 1 De Novo decisions, across 10 product codes in 1 review panel.
How long does FDA take to clear Abbott Diabetes Care, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Abbott Diabetes Care, Inc.'s cleared 510(k)s is 164 days. Since 2017: 178 days, versus 190 days for all cleared 510(k)s in the same product codes.
What devices does Abbott Diabetes Care, Inc. make?
Its most frequent FDA product codes are NBW (System, Test, Blood Glucose, Over The Counter, 19); QLG (Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems, 7); LFR (Glucose Dehydrogenase, Glucose, 5).
Has Abbott Diabetes Care, Inc. had device recalls?
openFDA lists 57 product recalls in 21 recall events by a recalling firm whose name matches Abbott Diabetes Care, Inc; the most recent began 2025-11-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 39 Abbott Diabetes Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Abbott Diabetes Care, 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.