510(k) Report

510(k) · Cleared

Cleared

GlucoLeader Enhance 2 Blood Glucose Monitoring System

K212248510(k) SpecialCleared Aug 29, 2022406-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 Aug 29, 2022 as substantially equivalent to K182428 (Hmd Biomedical, Inc., 2019) after a 406-day review. Its family tree reaches back 3 generations to 2003.

Decided
Aug 29, 2022
Review
406 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K023279 (2003). No later device cites it as a predicate yet.

×2: 2 generations cleared close together, K023279 (2003), K032985 (2003) K182428 · GlucoLeader Enhance Blood Glucose Monitoring System · Hmd Biomedical, Inc. · 201920002005201020152020
K182428 · GlucoLeader Enhance Blood Glucose Monitoring System · Hmd Biomedical, Inc. · 2019K032985 · Glucoleader Enhance Self-Monitoring of Blood Glucose System · Hmd Biomedical, Inc. · 2003K023279 · Glucoleader Value · Hmd Biomedical, Inc. · 20030
  1. Root · 3 generations backK023279 Glucoleader ValueHmd Biomedical, Inc. · 2003
  2. 2 generations backK032985 Glucoleader Enhance Self-Monitoring of Blood Glucose SystemHmd Biomedical, Inc. · 2003
  3. 1 generation backK182428 GlucoLeader Enhance Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2019
  4. This deviceK212248 GlucoLeader Enhance 2 Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K023279Glucoleader ValueHmd Biomedical, Inc.2003—
−2K032985Glucoleader Enhance Self-Monitoring of Blood Glucose SystemHmd Biomedical, Inc.2003—
−1K182428GlucoLeader Enhance Blood Glucose Monitoring SystemHmd Biomedical, Inc.2019—
0 (this device)K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemHmd Biomedical, Inc.2022—
FIG. 1 — Lineage of K212248, 2003–2022Source: 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), 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
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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
*K182428GlucoLeader Enhance Blood Glucose Monitoring System
Summary page 4
…lassification Product Code: NBW Regulation number: 862.1345 Device Class: II 510(k) Number: K182428 1/6 HMD BioMedical Inc.…
Hmd Biomedical, Inc.2019—

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 19 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
  • None of the 3 ancestors has a recall.

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. 2022, 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 GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used by…

Read the full statement (144 words)

The GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance 2 Blood Glucose Monitoring System is not for use in neonates.

Indications for use as stated in the FDA summary.

More from Hmd Biomedical, Inc.

10 FDA decisions under this applicant name. See the company

  • 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
  • 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/K212248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212248: GlucoLeader Enhance 2 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/K212248

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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