# Bionime Corporation

- Location (FDA's records): Great Neck, NY
- FDA decisions: 21 (2005–2024): 21 510(k) clearances
- Product codes: NBW (18), JQP (1), JJX (1), QRL (1)
- 510(k) review time since 2016: median 253 days, against 206 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 32 (25 its own); citations of its devices by later devices: 36 (25 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bionime Coporation: 2 (https://510kreport.com/company/bionime-coporation)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Genteel, LLC: 1 (https://510kreport.com/company/genteel)

## Firms that cite its devices most
- Bionime Coporation: 9 (https://510kreport.com/company/bionime-coporation)
- Medifun Corporation: 1 (https://510kreport.com/company/medifun)
- Ceragem Medisys, Inc.: 1 (https://510kreport.com/company/ceragem-medisys)

## Its most-cited devices
- K042678: Rightest Blood Glucose Monitoring System (2005), cited by 6
- K053635: Modification to Rightest Blood Glucose Monitoring System (2006), cited by 5
- K062567: Rightest Blood Glucose Monitoring System (2007), cited by 5
- K110737: Rightest Blood Glucose Monitoring System GM700 (2012), cited by 4
- K092052: Rightest Blood Glucose Monitoring System, Model GM550 (2010), cited by 3
- K120423: Bionime Rightest Blood Glucose Monitoring System, Model GM650 (2012), cited by 3

## Recent decisions
- K240637: RIGHTEST Blood Glucose Monitoring System Max Tel (Nov 4, 2024)
- K231192: RIGHTEST Blood Glucose Monitoring System Max Tel (Jan 19, 2024)
- K221062: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (Sep 26, 2022)
- K190564: Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB (Jun 2, 2019)
- K173638: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus (Aug 17, 2018)
- K173139: Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus (Jun 19, 2018)
- K170143: GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, (Jul 6, 2017)
- K161790: iGlucose Blood Glucose Monitoring System (May 2, 2017)

Source page: https://510kreport.com/company/bionime