510(k) Report

510(k) · Cleared

Cleared

PixoTest Blood Glucose Monitoring System

K163087510(k) TraditionalCleared Nov 2, 2017364-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

Ixensor Company, Ltd. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Nov 2, 2017 as substantially equivalent to K021827 (Roche Diagnostics Corp., 2002) after a 364-day review. Its family tree reaches back 6 generations to 1995.

Decided
Nov 2, 2017
Review
364 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K945887 (1995). 16 ancestors in all, the oldest K922888 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 3 other ancestors1998: 3 other ancestors1993: 1 other ancestor1996: 1 other ancestor1992: 2 other ancestorsK945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995K970707 · Elect II Blood Glucose Monitoring System · Selfcare, Inc. · 1997K992684 · Freestyle Blood Glucose Monitoring System · Abbott Diabetes Care, Inc. · 2000 · recalledK012324 · Accu-Chek Active Test System · Roche Diagnostics Corp. · 2001×2: 2 generations cleared close together, K021448 (2002), K021827 (2002) 199019952000200520102015
Other ancestors, by generation 3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 3 other ancestors K021827 · Modification to Accu-Chek Active System · Roche Diagnostics Corp. · 2002 · recalledK021448 · Modification to Accu-Chek Active System · Roche Diagnostics Corp. · 2002K012324 · Accu-Chek Active Test System · Roche Diagnostics Corp. · 2001K992684 · Freestyle Blood Glucose Monitoring System · Abbott Diabetes Care, Inc. · 2000 · recalledK970707 · Elect II Blood Glucose Monitoring System · Selfcare, Inc. · 1997K945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995−50
  1. Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 5 generations backK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
  3. 4 generations backK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
  4. 3 generations backK012324 Accu-Chek Active Test SystemRoche Diagnostics Corp. · 2001
  5. 2 generations backK021448 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002
  6. 1 generation backK021827 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002 · Recalled
  7. This deviceK163087 PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−5K970707Elect II Blood Glucose Monitoring SystemSelfcare, Inc.1997—
−4K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20002
−3K012324Accu-Chek Active Test SystemRoche Diagnostics Corp.2001—
−2K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.2002—
−1K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20021
0 (this device)K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199610
199830
200030
FIG. 1 — Lineage of K163087, 1995–2017Source: 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
*K021827Modification to Accu-Chek Active System
Summary page 5
…BGMS Name: Accu-Chek Active System Device Company: Roche Diagnostics Corporation 510(K) Number: K021827 7. Comparison to Predicate Devices: Subject Device – PixoTest BGMS…
Roche Diagnostics Corp.20021

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 22 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
  • 4 of the 16 ancestors have 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. 2017, 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 PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip, PixoTest Uni-Clip, and the PixoHealth App as the display component of the system. The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. The PixoTest Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic…

Read the full statement (121 words)

The PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip, PixoTest Uni-Clip, and the PixoHealth App as the display component of the system.

The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip.

The PixoTest Blood Glucose Monitoring System 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 system is intended for single person use only and should not be shared. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

Indications for use as stated in the FDA summary.

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/K163087 · printed Nov 5, 2026

Cite this page

510(k) Report. “K163087: PixoTest Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163087

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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