# Abbott Diabetes Care, Inc.

- Location (FDA's records): Alameda, CA
- FDA decisions: 42 (2000–2026): 39 510(k) clearances, 1 De Novo grant and 2 original PMA approvals
- Names in FDA's records: Abbott Diabetes Care, Inc. (39); Abbott Diabetes Care (3)
- Product codes: NBW (19), QLG (7), LFR (5), LZG (3), QBJ (3), JIN (1), SBH (1), MDS (1), PZE (1), SJD (1)
- 510(k) review time since 2016: median 161 days, against 239 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 67 (48 its own); citations of its devices by later devices: 64 (48 its own)
- Recalls linked to its devices: 27 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 8 (https://510kreport.com/company/abbott-laboratories)
- Boehringer Mannheim Corp.: 3 (https://510kreport.com/company/boehringer-mannheim)
- Medisense, Inc.: 2 (https://510kreport.com/company/medisense)
- Dexcom, Inc.: 1 (https://510kreport.com/company/dexcom)
- Medtronic Minimed: 1 (https://510kreport.com/company/medtronic-minimed)
- Selfcare, Inc.: 1 (https://510kreport.com/company/selfcare)
- Amira Medical, Inc.: 1 (https://510kreport.com/company/amira-medical)
- Animas Corp.: 1 (https://510kreport.com/company/animas)

## Firms that cite its devices most
- Abbott Laboratories: 5 (https://510kreport.com/company/abbott-laboratories)
- Nova Biomedical Corp.: 2 (https://510kreport.com/company/nova-biomedical)
- American Biological Technologies, Inc.: 1 (https://510kreport.com/company/american-biological-technologies)
- Abott Laboratories: 1 (https://510kreport.com/company/abott-laboratories)
- Agamatrix, Inc.: 1 (https://510kreport.com/company/agamatrix)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Specialty Medical Supplies: 1 (https://510kreport.com/company/specialty-medical-supplies)
- Bigfoot Biomedical, Inc.: 1 (https://510kreport.com/company/bigfoot-biomedical)

## Its most-cited devices
- K992684: Freestyle Blood Glucose Monitoring System (2000), cited by 8
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005 (2003), cited by 6
- K012014: Modification to Blood Glucose Monitoring System (2001), cited by 5
- K000582: Freestyle Blood Glucose Monitoring System, Cat NO 11001 (2000), cited by 5
- K994433: Connect Data Management System (2000), cited by 3
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001 (2006), cited by 3

## Recent decisions
- DEN250049: Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System (Aug 25, 2026)
- K233861: Libre Rio Continuous Glucose Monitoring System (Jun 7, 2024)
- K233537: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (Apr 23, 2024)
- K223435: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (Apr 13, 2023)
- K222447: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (Mar 3, 2023)
- K223537: FreeStyle Libre 2 System, FreeStyle Libre 3 System (Feb 21, 2023)
- K212132: FreeStyle Libre 3 Continuous Glucose Monitoring System (May 26, 2022)
- K213996: FreeStyle Libre 3 Continuous Glucose Monitoring System (May 26, 2022)

Source page: https://510kreport.com/company/abbott-diabetes-care