510(k) Report

510(k) · Cleared

Cleared

Precichek NS-101 Poct Professional Blood Glucose Monitoring System

K113314510(k) TraditionalCleared Nov 9, 2012366-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. · LFR Glucose Dehydrogenase, Glucose

Cleared on Nov 9, 2012 as substantially equivalent to K023194 (Lifescan, Inc., 2002) and 1 other predicate after a 366-day review. Its family tree reaches back 2 generations to 2003.

Decided
Nov 9, 2012
Review
366 days
Class
Class II
Product code
LFR
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K023279 (2003). 3 ancestors in all, the oldest K023194 (2002). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK023279 · Glucoleader Value · Hmd Biomedical, Inc. · 2003K032985 · Glucoleader Enhance Self-Monitoring of Blood Glucose System · Hmd Biomedical, Inc. · 200320002002200420062008201020122014
Other ancestors, by generation 1 generation back: 1 other ancestor K032985 · Glucoleader Enhance Self-Monitoring of Blood Glucose System · Hmd Biomedical, Inc. · 2003K023279 · Glucoleader Value · Hmd Biomedical, Inc. · 20030
  1. Root · 2 generations backK023279 Glucoleader ValueHmd Biomedical, Inc. · 2003
  2. 1 generation backK032985 Glucoleader Enhance Self-Monitoring of Blood Glucose SystemHmd Biomedical, Inc. · 2003
  3. This deviceK113314 Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K023279Glucoleader ValueHmd Biomedical, Inc.2003—
−1K032985Glucoleader Enhance Self-Monitoring of Blood Glucose SystemHmd Biomedical, Inc.2003—
0 (this device)K113314Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemHmd Biomedical, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K113314, 2003–2012Source: 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 LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K023194Suresteppro/Surestepflexx Professional Blood Glucose Management System
Summary page 1
…Management System Common name: Blood Glucose Test System Submitter: Life Scan, Inc. 510(k) no.: K023 194 Product code: NBW, CGA Commonname:Glucose Control Solution Submitter:…
Lifescan, Inc.20022
*K032985Glucoleader Enhance Self-Monitoring of Blood Glucose System
Summary page 2
…: NBW, CGA Commonname:Glucose Control Solution Submitter: HMD Biomedical, Inc. 510(k) no.: K032985 Product code: JJX 4. Device Description PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring Syste…
Hmd 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 9 years and passes through 1 company; a new generation was cleared every 9.1 years on median.
  • 1 of the 3 ancestors has a recall of any class.

How does its category compare?

All LFR devices

LFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LFR

1in 2015

2007: 12009: 12011: 62012: 132013: 32014: 32015: 1
2007high 13 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFR

161in 2014

2011: 296 days median2012: 152 days median2013: 212 days median2014: 161 days median
2007high 296 (2011) · low 152 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFR

1in 2012

2007: 32008: 12009: 42011: 12012: 1
2007high 4 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFR

827in 2025

2007: 23,8192008: 6,5842009: 10,8232010: 4,8652011: 3,8022012: 3,3412013: 3,8212014: 3,9602015: 3,3662016: 2,1452017: 1032018: 1082019: 1082020: 1322021: 1642022: 1012023: 1032024: 1712025: 827
2007high 23,819 (2007) · low 101 (2022)2025

MAUDE reports naming product code LFR, 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
20071—323,819
20080—16,584
20091—410,823
20100—04,865
2011629613,802
20121315213,341
2013321203,821
2014316103,960
20151—03,366
20160—02,145
20170—0103
20180—0108
20190—0108
20200—0132
20210—0164
20220—0101
20230—0103
20240—0171
20250—0827
20260—0—

What is it indicated for?

The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by health care professionals in a clinical setting: The PRECICHEK NS-101 POCT Professional Blood Glucose…

Read the full statement (230 words)

The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by health care professionals in a clinical setting:

The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The PRECICHEI( NS-1O1 POCT Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The PRECICHEK KP Blood Glucose Test Strip is for use with the PRECICHEK NS-1O1 POCT Professional Blood Glucose Meter to quantitatively measure glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples.

The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP 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 LFR

The LFR category page

  • K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories · 2015
  • K142089Accu-Chek Aviva Expert SystemRoche Diagnostics Corporation · 2014
  • K133537EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2014
  • K131727Cera-Chek 1070 Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2014
  • K131366Accu-Chek Aviva Expert Blood Glucose Monitoring SystemRoche Diagnostics Operations, Inc. · 2013

https://510kreport.com/device/K113314 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113314: Precichek NS-101 Poct Professional 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/K113314

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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