510(k) Report

510(k) · Cleared

Recalled · 2007

Modification to Rightest Blood Glucose Monitoring System

K053635510(k) TraditionalCleared Feb 21, 200654-day reviewClass II21 CFR 862.1345Recalls 1

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 Feb 21, 2006 as substantially equivalent to K042678 (Bionime Corporation, 2005) after a 54-day review. Its family tree reaches back 2 generations to 2003. 17 later devices descend from it. It has been recalled once.

Decided
Feb 21, 2006
Review
54 days
Class
Class II
Product code
NBW
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K024194 (2003). 17 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2008: 3 descendants cleared2010: 1 descendant cleared2007: 1 descendant cleared2014: 2 descendants cleared2013: 3 descendants cleared2015: 2 descendants cleared2012: 2 descendants cleared2017: 2 descendants cleared2018: 1 descendant clearedK024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalledK042678 · Rightest Blood Glucose Monitoring System · Bionime Corporation · 2005 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant K042678 · Rightest Blood Glucose Monitoring System · Bionime Corporation · 2005 · recalledK024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalled0
  1. Root · 2 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
  2. 1 generation backK042678 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2005 · Recalled
  3. This deviceK053635 Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 2006
  4. Descendant · cites it directly · 16 of its ownK062567 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · Recalled
  5. Descendant · cites it directly · 10 of its ownK092052 Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 2010
  6. Descendant · 2 generations on · 4 of its ownK110737 Rightest Blood Glucose Monitoring System GM700Bionime Corporation · 2012
  7. Descendant · 2 generations on · 3 of its ownK143387 GE333 Blood Glucose Monitoring SystemBionime Coporation · 2015
  8. Descendant · 2 generations on · 3 of its ownK120423 Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation · 2012

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32010: 12012: 22013: 32014: 22015: 22017: 22018: 1
2007high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all
  • K062567Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · cites it directly16descendants
  • K092052Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 2010 · cites it directly10descendants
  • K110737Rightest Blood Glucose Monitoring System GM700Bionime Corporation · 2012 · 2 generations on4descendants
  • K143387GE333 Blood Glucose Monitoring SystemBionime Coporation · 2015 · 2 generations on3descendants
  • K120423Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation · 2012 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc.20035
−1K042678Rightest Blood Glucose Monitoring SystemBionime Corporation20051
0 (this device)K053635Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation2006—
+1K062567Rightest Blood Glucose Monitoring SystemBionime Corporation20071
+1K092052Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation2010—
+2K110737Rightest Blood Glucose Monitoring System GM700Bionime Corporation2012—
+2K143387GE333 Blood Glucose Monitoring SystemBionime Coporation2015—
+2K120423Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
201010
201220
201330
201420
201520
201720
201810
FIG. 1 — Lineage of K053635, 2003–2018Source: 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
*K042678Rightest Blood Glucose Monitoring System
Summary page 2
…onitoring System noted below. Name: Rightest Blood Glucose Monitoring System Device Company: Bionime Corporation 510(K) Number: K042678 7. Comparison to Predicate Devices: Similarities Item De…
Bionime Corporation20051

Also cleared against K042678: 5 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K062567Rightest Blood Glucose Monitoring SystemBionime Corporation200716
K092052Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation201010
K081451Rightest Blood Glucose Monitoring System, Model GM100Bionime Corporation20082
K081450Rightest Blood Glucose Monitoring System, Model GM110Bionime Corporation20080
K072054Rightest Blood Glucose Monitoring System, Model GM310Bionime Corporation20080

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 26, 2007Not classifiedZ-0728-2008Software designAbnormal Memory Recall: When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM depending on when the user is recalling the memory stored in the meter. This will cause…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K062567 (Bionime Corporation, 2007) has gone furthest, with 16 descendants of its own.
  • 5 other devices also cite its predicate K042678.

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.

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 Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System.

This device is not intended for testing neonate blood samples.

Special condition for use statement(s): Rightest System provides plasma equivalent results.

Indications for use as stated in the FDA summary.

Also cleared against K042678

5 other devices cite the same predicate.

  • K092052Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation · 2010
  • K081451Rightest Blood Glucose Monitoring System, Model GM100Bionime Corporation · 2008
  • K081450Rightest Blood Glucose Monitoring System, Model GM110Bionime Corporation · 2008
  • K072054Rightest Blood Glucose Monitoring System, Model GM310Bionime Corporation · 2008
  • K062567Rightest Blood Glucose Monitoring SystemBionime Corporation · 20071 recall

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/K053635 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053635: Modification to Rightest Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053635

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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