FDA applicant

Bionime Corporation

Great Neck, NY21 decisions2005–20241 recall

FDA records 21 decisions for Bionime Corporation (Great Neck, NY) from 2005 to 2024: 21 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and JQP (Calculator/Data Processing Module, For…). Since 2016 its 510(k)s took a median of 253 days from receipt to decision, against 206 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 25 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Bionime Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2007high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Bionime Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bionime Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

NBWSystem, Test, Blood Glucose, Over The Counter18decisions
JQPCalculator/Data Processing Module, For Clinical Use1decision
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision
QRLMultiple Use Blood Lancet For Single Patient Use Only1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 253 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 206 days; 2 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 32 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 36 times; 25 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K042678Rightest Blood Glucose Monitoring SystemBionime Corporation · 20056cite it
K053635Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 20065cite it
K062567Rightest Blood Glucose Monitoring SystemBionime Corporation · 20075cite it
K110737Rightest Blood Glucose Monitoring System GM700Bionime Corporation · 20124cite it
K092052Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 20103cite it
K120423Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation · 20123cite it

What has FDA decided for it lately?

K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation · 2022
K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBBionime Corporation · 2019
K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood…Bionime Corporation · 2018
K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz PlusBionime Corporation · 2018
K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose…Bionime Corporation · 2017
K161790iGlucose Blood Glucose Monitoring SystemBionime Corporation · 2017

All 21 as Bionime Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

K042678Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus…Nov 26, 2007

Other applicant names beginning “Bionime”

FDA records each applicant name separately; these may or may not be the same firm.

Bionime Coporation 3