510(k) Report

510(k) · Cleared

Cleared

Test, Blood Glucose System

K120064510(k) TraditionalCleared Sep 5, 2012240-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 5, 2012 as substantially equivalent to K110571 (Telcare, Inc., 2011) and 1 other predicate after a 240-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.

Decided
Sep 5, 2012
Review
240 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K011233 (2001). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2010: 1 other ancestor2008: 1 other ancestor2007: 1 other ancestor2014: 1 descendant clearedK011233 · 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 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant K110571 · 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 · 3 generations backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
  2. 2 generations backK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
  3. 1 generation backK110571 Telcare Blood Glucose Monitoring System, Test Strips, Control…Telcare, Inc. · 2011 · Recalled
  4. This deviceK120064 Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012
  5. Descendant · cites it directly · 0 of its ownK131173 FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320
200710
200810
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K120064, 2001–2014Source: 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? (2)

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
*K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…
Summary page 1
…care Blood Glucose Monitoring System Common name: Blood Glucose Test System Submitter: Telcare, Inc. 510(k) no.: K110571 Product code: CGA, NBW, JJX, JQP HMD Bi…
Telcare, Inc.20111
*K032985Glucoleader Enhance Self-Monitoring of Blood Glucose System
Summary page 2
…HMD BioMedical Inc. Common name: Glucose Control Solution Submitter: HMD BioMedical, Inc. 510(k) no.: K032985 Product code: JJX 4. Device Description PRECICHEK Cloudia Blood Glucose Monitoring System consists of: (1)…
Hmd Biomedical, Inc.2003—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.20140

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 11 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K131173 (Hmd Biomedical, Inc., 2014) has gone furthest, with 0 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. 2012, 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 PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people…

Read the full statement (185 words)

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

The PRECICHEK Cloudia 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 PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Indications for use as stated in the FDA summary.

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
  • K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014
  • K121433Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring…Hmd Biomedical, Inc. · 2013

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/K120064 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120064: Test, Blood Glucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120064

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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