510(k) Report

510(k) · Cleared

Cleared

RIGHTEST Blood Glucose Monitoring System Max Tel

K240637510(k) TraditionalCleared Nov 4, 2024243-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 Nov 4, 2024 as substantially equivalent to K231192 (Bionime Corporation, 2024) after a 243-day review. Its family tree reaches back 4 generations to 2007.

Decided
Nov 4, 2024
Review
243 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K070585 (2007). No later device cites it as a predicate yet.

K070585 · Accu-Chek Performa System · Roche Diagnostics Corp. · 2007 · recalledK140210 · Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720 · Bionime Corporation · 2014K173638 · 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 · Bionime Corporation · 2018K231192 · RIGHTEST Blood Glucose Monitoring System Max Tel · Bionime Corporation · 202420052010201520202025
K231192 · RIGHTEST Blood Glucose Monitoring System Max Tel · Bionime Corporation · 2024K173638 · 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 · Bionime Corporation · 2018K140210 · Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720 · Bionime Corporation · 2014K070585 · Accu-Chek Performa System · Roche Diagnostics Corp. · 2007 · recalled0
  1. Root · 4 generations backK070585 Accu-Chek Performa SystemRoche Diagnostics Corp. · 2007 · Recalled
  2. 3 generations backK140210 Rightest Blood Glucose Monitoring System ( GM720, Rightest…Bionime Corporation · 2014
  3. 2 generations backK173638 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose…Bionime Corporation · 2018
  4. 1 generation backK231192 RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
  5. This deviceK240637 RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K070585Accu-Chek Performa SystemRoche Diagnostics Corp.20072
−3K140210Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS…Bionime Corporation2014—
−2K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose…Bionime Corporation2018—
−1K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation2024—
0 (this device)K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation2024—
FIG. 1 — Lineage of K240637, 2007–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K231192RIGHTEST Blood Glucose Monitoring System Max Tel
Summary page 6
…1. 6.1 Name: RIGHTEST Blood Glucose Monitoring System Max Plus Device Company: Bionime Corporation 510(K) Number: K231192 RIGHTEST BGMS MAX Tel 7. Comparison…
Bionime Corporation2024—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
  • 1 of the 4 ancestors has a recall of any class.

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. 2024, 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?

RIGHTEST Blood Glucose Monitoring System Max Tel 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. It is intended to be used by a single person and should not be shared. RIGHTEST Blood Glucose Monitoring System Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the…

Read the full statement (139 words)

RIGHTEST Blood Glucose Monitoring System Max Tel 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. It is intended to be used by a single person and should not be shared.

RIGHTEST Blood Glucose Monitoring System Max Tel 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. It 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 Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

Indications for use as stated in the FDA summary.

More from Bionime Corporation

21 FDA decisions under this applicant name. See the company

  • 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

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/K240637 · printed Nov 5, 2026

Cite this page

510(k) Report. “K240637: RIGHTEST Blood Glucose Monitoring System Max Tel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240637

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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