510(k) Report

510(k) · Cleared

Cleared

FIA Blood Glucose Monitoring System (G2)

K131173510(k) TraditionalCleared Sep 18, 2014511-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

Hmd Biomedical, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Sep 18, 2014 as substantially equivalent to K120064 (Hmd Biomedical, Inc., 2012) after a 511-day review. Its family tree reaches back 4 generations to 2001.

Decided
Sep 18, 2014
Review
511 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K011233 (2001). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors2010: 1 other ancestor2008: 1 other ancestor2007: 1 other ancestorReference device: K032985 · Glucoleader Enhance Self-Monitoring of Blood Glucose System · Hmd Biomedical, Inc. · 2003K011233 · Modification to Glucosure BGM System, Model 221100 · Apex BioTechnology Corp. · 2001 · recalledK062799 · Gluco Track Blood Glucose Monitoring System · Apex BioTechnology Corp. · 2007K110571 · Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use · Telcare, Inc. · 2011 · recalledK120064 · Test, Blood Glucose System · Hmd Biomedical, Inc. · 20122000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 1 other ancestor K120064 · Test, Blood Glucose System · Hmd Biomedical, Inc. · 2012K110571 · Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use · Telcare, Inc. · 2011 · recalledK062799 · Gluco Track Blood Glucose Monitoring System · Apex BioTechnology Corp. · 2007K011233 · Modification to Glucosure BGM System, Model 221100 · Apex BioTechnology Corp. · 2001 · recalled0
  1. Root · 4 generations backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
  2. 3 generations backK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
  3. 2 generations backK110571 Telcare Blood Glucose Monitoring System, Test Strips, Control…Telcare, Inc. · 2011 · Recalled
  4. 1 generation backK120064 Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012
  5. This deviceK131173 FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011233Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp.20011
−3K062799Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp.2007—
−2K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions…Telcare, Inc.20111
−1K120064Test, Blood Glucose SystemHmd Biomedical, Inc.2012—
0 (this device)K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320
200710
200810
201010
FIG. 1 — Lineage of K131173, 2001–2014Source: 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
*K120064Test, Blood Glucose System
Summary page 1
…cate Device Trade/Proprietary name: PRECICHEK Cloudia Blood Glucose Monitoring System Common name: Blood Glucose Test System Submitter: HMD BioMedical Inc. 510(k) no.: K120064 Product code: NBW, LFR 1 HMD BioMedical Inc. Common name: Glucose Control Solution Submitter: HMD BioMedical,…
Hmd Biomedical, Inc.2012—
†K032985Glucoleader Enhance Self-Monitoring of Blood Glucose SystemHmd Biomedical, Inc.2003—

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 13 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
  • 2 of the 9 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. 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 FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared. The FIA Blood Glucose Monitoring System (G2) is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an…

Read the full statement (183 words)

The FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared.

The FIA Blood Glucose Monitoring System (G2) 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 FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The FIA Blood Glucose Test Strips (G2) are for use with the FIA Blood Glucose Meter (G2) to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The FIA Glucose Control Solutions are for use with the FIA Blood Glucose Meter (G2) and FIA Blood Glucose Test Strips (G2) to check that the meter and test strips are working together properly and that the test is performing correctly.

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

More from Hmd Biomedical, Inc.

10 FDA decisions under this applicant name. See the company

  • K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2022
  • K182428GlucoLeader Enhance Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2019
  • K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife…Hmd Biomedical, Inc. · 2015
  • K121433Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring…Hmd Biomedical, Inc. · 2013
  • K113314Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2012

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/K131173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131173: FIA Blood Glucose Monitoring System (G2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131173

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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