510(k) Report

510(k) · Cleared

Cleared

Wavesense Diabetes Manager Model Version 1.3.4

K101597510(k) SpecialCleared Oct 18, 2010132-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

Agamatrix · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Oct 18, 2010 as substantially equivalent to K062434 (Agamatrix, 2006) after a 132-day review. Its family tree reaches back 3 generations to 1995. 11 later devices descend from it.

Decided
Oct 18, 2010
Review
132 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K952279 (1995). 11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2013: 3 descendants cleared2016: 2 descendants cleared2014: 1 descendant cleared2015: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant clearedK952279 · Precision Link Blood Glucose Data Management System · Medisense, Inc. · 1995K994433 · Connect Data Management System · Abbott Diabetes Care, Inc. · 2000 · recalledK062434 · Zero-Click Data Management System, Model 8000-01528 · Agamatrix · 20061995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K062434 · Zero-Click Data Management System, Model 8000-01528 · Agamatrix · 2006K994433 · Connect Data Management System · Abbott Diabetes Care, Inc. · 2000 · recalledK952279 · Precision Link Blood Glucose Data Management System · Medisense, Inc. · 19950
  1. Root · 3 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
  2. 2 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
  3. 1 generation backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
  4. This deviceK101597 Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 2010
  5. Descendant · cites it directly · 9 of its ownK103544 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2011
  6. Descendant · 2 generations on · 4 of its ownK131230 Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014
  7. Descendant · 3 generations on · 2 of its ownK150817 Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK152365 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
  9. Descendant · 2 generations on · 1 of its ownK130535 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2013

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 12013: 32014: 12015: 22016: 22017: 12018: 1
2011high 3 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 11 · See all
  • K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc. · 2011 · cites it directly9descendants
  • K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014 · 2 generations on4descendants
  • K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · 3 generations on2descendants
  • K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016 · 2 generations on1descendant
  • K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K952279Precision Link Blood Glucose Data Management SystemMedisense, Inc.1995—
−2K994433Connect Data Management SystemAbbott Diabetes Care, Inc.20001
−1K062434Zero-Click Data Management System, Model 8000-01528Agamatrix2006—
0 (this device)K101597Wavesense Diabetes Manager Model Version 1.3.4Agamatrix2010—
+1K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application…Agamatrix, Inc.2011—
+2K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc.2014—
+3K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.20151
+2K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc.2016—
+2K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201330
201410
201520
201620
201710
201810
FIG. 1 — Lineage of K101597, 1995–2018Source: 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
*K062434Zero-Click Data Management System, Model 8000-01528
Summary page 1
…lassification Name: NBW, JQP Class I 3. Predicate Device Zero-Click Data Management System 5 10(k) number: k062434 4. Device Description The WaveSense Diabetes Manager (WDM) application (app) is a digital logbook and diabetes…
Agamatrix2006—

Also cleared against K062434: 1 other device →

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc.20119
K132821Agamatrix Health ManagerAgamatrix, Inc.20130

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 15 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K103544 (Agamatrix, Inc., 2011) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K062434.

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. 2010, 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 WaveSense Diabetes Manager (WOM) application (app) is intended for use in the home and professional settings to aid individuals with diabetes and their healthcare professionals; in the review, analysis and evaluation of blood glucose readings to support an effective diabetes managemnent-program. The WaveSense Diabetes Manager application is a digital logbook and. diabetes management tool designed to operate using the iPhone Operating System platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled blood glucose meter (BGM) with a mini-USB poll.

Indications for use as stated in the FDA summary.

Also cleared against K062434

1 other device cites the same predicate.

  • K100937PC Care Blood Glucose Data Management SoftwareI-Sens, Inc. · 2010

More from Agamatrix

7 FDA decisions under this applicant name. See the company

  • K241304WaveSense Jazz Blood Glucose Monitoring SystemAgamatrix · 2024
  • K073573Wavesense Keynote Codeless Blood Glucose Monitoring SystemAgamatrix · 2008
  • K072413Modification to: Jazz Blood Glucose Monitoring SystemAgamatrix · 2007
  • K071393Jazz Blood Glucose Monitoring SystemAgamatrix · 2007
  • K063409Liberty Blood Glucose Monitoring System, Model 8000-0067Agamatrix · 2007

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/K101597 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101597: Wavesense Diabetes Manager Model Version 1.3.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101597

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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