510(k) Report

510(k) · Cleared

Cleared

Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720

K140210510(k) TraditionalCleared Aug 22, 2014206-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bionime Corporation · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Aug 22, 2014 as substantially equivalent to K070585 (Roche Diagnostics Corp., 2007) after a 206-day review. Its family tree reaches back 1 generation to 2007. 4 later devices descend from it.

Decided
Aug 22, 2014
Review
206 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K070585 (2007). 4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2018: 1 descendant cleared2024: 2 descendants clearedK070585 · Accu-Chek Performa System · Roche Diagnostics Corp. · 2007 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K070585 · Accu-Chek Performa System · Roche Diagnostics Corp. · 2007 · recalled0
  1. Root · 1 generation backK070585 Accu-Chek Performa SystemRoche Diagnostics Corp. · 2007 · Recalled
  2. This deviceK140210 Rightest Blood Glucose Monitoring System ( GM720, Rightest…Bionime Corporation · 2014
  3. Descendant · cites it directly · 2 of its ownK173638 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose…Bionime Corporation · 2018
  4. Descendant · 2 generations on · 1 of its ownK231192 RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
  5. Descendant · 3 generations on · 0 of its ownK240637 RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
  6. Descendant · cites it directly · 0 of its ownK190564 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood…Bionime Corporation · 2019

Most influential descendants

Showing 4 of 4 · See all
  • K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…Bionime Corporation · 2018 · cites it directly2descendants
  • K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024 · 2 generations on1descendant
  • K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024 · 3 generations on0descendants
  • K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring…Bionime Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070585Accu-Chek Performa SystemRoche Diagnostics Corp.20072
0 (this device)K140210Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS…Bionime Corporation2014—
+1K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose…Bionime Corporation2018—
+2K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation2024—
+3K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation2024—
+1K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose…Bionime Corporation2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202420
FIG. 1 — Lineage of K140210, 2007–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NBW device

  1. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K070585Accu-Chek Performa System
Summary page 8
…Name: ACCU-CHEK Performa Blood Glucose Monitoring System Device Company: Roche Diagnostics Corporation 510(K) Number: K070585 8-2 510k summary (20140820) 7. Comparisons…
Roche Diagnostics Corp.20072

Also cleared against K070585: 1 other device →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…Bionime Corporation20182
K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring…Bionime Corporation20190

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K173638 (Bionime Corporation, 2018) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K070585.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The Rightest Professional Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood. The Rightest Professional Blood Glucose Monitoring System GM720 is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional…

Read the full statement (344 words)

The Rightest Professional Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood. The Rightest Professional Blood Glucose Monitoring System GM720 is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Rightest Professional Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for diabetes, nor for testing neonate blood samples. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Professional Blood Glucose Test Strips GS720 are for use with the Rightest Professional Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood samples.

The Rightest Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM720 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM720 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS720 are for use with the Rightest Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K070585

1 other device cites the same predicate.

  • K141351Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring SystemBiotest Medical Corp. · 2015

More from Bionime Corporation

21 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K140210 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140210: Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140210

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026