510(k) Report

510(k) · Cleared

Cleared

Nova Max Blood Glucose Monitor System, 90001,90002

K070255510(k) TraditionalCleared Jun 13, 2007138-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

Nova Biomedical Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jun 13, 2007 after a 138-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 17 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.

Decided
Jun 13, 2007
Review
138 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
0

16 later devices descend from it, 4 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2010: 2 descendants cleared, 1 with a Class I recall12016: 2 descendants cleared2012: 2 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2013: 2 descendants cleared2021: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK070255 Nova Max Blood Glucose Monitor System, 90001,90002Nova Biomedical Corp. · 2007
  2. Descendant · cites it directly · 10 of its ownK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
  3. Descendant · cites it directly · 3 of its ownK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
  4. Descendant · 2 generations on · 2 of its ownK161738 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and…Taidoc Technology Corporation · 2016
  5. Descendant · 2 generations on · 1 of its ownK170463 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood…I-Sens, Inc. · 2018
  6. Descendant · cites it directly · 1 of its ownK160156 StatStrip Xpress Blood Glucose Monitoring SystemNova Biomedical Corporation · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2010: 22012: 22013: 22016: 22017: 12018: 32020: 12021: 12022: 2
2010high 3 (2018) · low 0 (2011)2026

Class I recalls in this family

  • K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…cites it directly · 2010

Most influential descendants

Showing 5 of 16 · See all
  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Nova Biomedical Corp. · 2010 · cites it directly10descendants
  • K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation · 2012 · cites it directly3descendants
  • K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Taidoc Technology Corporation · 2016 · 2 generations on2descendants
  • K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc. · 2018 · 2 generations on1descendant
  • K160156StatStrip Xpress Blood Glucose Monitoring SystemNova Biomedical Corporation · 2016 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070255Nova Max Blood Glucose Monitor System, 90001,90002Nova Biomedical Corp.2007—
+1K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus…Nova Biomedical Corp.2010Class I
+1K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation2012—
+2K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone…Taidoc Technology Corporation2016—
+2K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone…I-Sens, Inc.2018—
+1K160156StatStrip Xpress Blood Glucose Monitoring SystemNova Biomedical Corporation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201021
201220
201320
201620
201710
201830
202010
202110
202220
FIG. 1 — Lineage of K070255, 2007–2022Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control… Class INova Biomedical Corp.201010
K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123
K160156StatStrip Xpress Blood Glucose Monitoring SystemNova Biomedical Corporation20161
K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp.20100

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 110 Class I recalls

What does this lineage say?

  • Of its descendants, K091547 (Nova Biomedical Corp., 2010) has gone furthest, with 10 descendants of its own.

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. 2007, 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—

More from Nova Biomedical Corp.

89 FDA decisions under this applicant name. See the company

  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011
  • K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp. · 2010
  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 201010 Class I recalls
  • K070960Nova Statstrip Xpress Glucose Hospital Meter SystemNova Biomedical Corp. · 20071 recall
  • K070068Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test StripsNova Biomedical Corp. · 20075 recalls

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/K070255 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070255: Nova Max Blood Glucose Monitor System, 90001,90002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070255

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026