510(k) Report

510(k) · Cleared

Cleared

Insulia Diabetes Management Companion

K202596510(k) SpecialCleared Jun 4, 2021269-day reviewClass II21 CFR 868.1890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Voluntis Sa. · NDC Calculator, Drug Dose

Cleared on Jun 4, 2021 as substantially equivalent to K172177 (Voluntis Sa., 2017) after a 269-day review. Its family tree reaches back 10 generations to 2001.

Decided
Jun 4, 2021
Review
269 days
Class
Class II
Product code
NDC
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K010362 (2001). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2008: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2003: 3 other ancestorsK010362 · Accu-Chek Comfort Curve Test Strip · Roche Diagnostics Corp. · 2001 · recalledK043474 · Accu-Chek Aviva System · Roche Diagnostics Corp. · 2005 · recalledK060620 · Accu-Chek Aviva Test Strips · Roche Diagnostics Corp. · 2006 · recalledK101299 · Accu-Chek Aviva Plus Blood Glucose Monitoring System · Roche Diagnostics · 2011K111353 · Accu-Check Combo System · Roche Diagnostics · 2012 · recalled×2: 2 generations cleared close together, K141929 (2015), K150910 (2015) K161433 · Insulia Diabetes Management Companion · Voluntis Sa. · 2016K170669 · Insulia Diabetes Management Companion · Voluntis Sa. · 2017 · recalledK172177 · Insulia Diabetes Management Companion · Voluntis Sa. · 2017 · recalled20002005201020152020
Other ancestors, by generation 4 generations back: 1 other ancestor7 generations back: 2 other ancestors8 generations back: 1 other ancestor9 generations back: 3 other ancestors K172177 · Insulia Diabetes Management Companion · Voluntis Sa. · 2017 · recalledK170669 · Insulia Diabetes Management Companion · Voluntis Sa. · 2017 · recalledK161433 · Insulia Diabetes Management Companion · Voluntis Sa. · 2016K150910 · ACCU-CHEK Connect Diabetes Management App · Roche Diabetes Care, Inc. · 2015 · recalledK141929 · Accu-Chek Connect Diabetes Management App · Roche Diagnostics Corporation · 2015 · recalledK111353 · Accu-Check Combo System · Roche Diagnostics · 2012 · recalledK101299 · Accu-Chek Aviva Plus Blood Glucose Monitoring System · Roche Diagnostics · 2011K060620 · Accu-Chek Aviva Test Strips · Roche Diagnostics Corp. · 2006 · recalledK043474 · Accu-Chek Aviva System · Roche Diagnostics Corp. · 2005 · recalledK010362 · Accu-Chek Comfort Curve Test Strip · Roche Diagnostics Corp. · 2001 · recalled−10−50
  1. Root · 10 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
  2. 6 generations between
  3. 3 generations backK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
  4. 2 generations backK170669 Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · Recalled
  5. 1 generation backK172177 Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · Recalled
  6. This deviceK202596 Insulia Diabetes Management CompanionVoluntis Sa. · 2021
Show all 10 generations
  1. Root · 10 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
  2. 9 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
  3. 8 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
  4. 7 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
  5. 6 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
  6. 5 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
  7. 4 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
  8. 3 generations backK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
  9. 2 generations backK170669 Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · Recalled
  10. 1 generation backK172177 Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · Recalled
  11. This deviceK202596 Insulia Diabetes Management CompanionVoluntis Sa. · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K010362Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp.20016
−9K043474Accu-Chek Aviva SystemRoche Diagnostics Corp.200510
−8K060620Accu-Chek Aviva Test StripsRoche Diagnostics Corp.20061
−7K101299Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics2011—
−6K111353Accu-Check Combo SystemRoche Diagnostics20123
−5K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation20151
−4K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc.20156
−3K161433Insulia Diabetes Management CompanionVoluntis Sa.2016—
−2K170669Insulia Diabetes Management CompanionVoluntis Sa.20171
−1K172177Insulia Diabetes Management CompanionVoluntis Sa.20171
0 (this device)K202596Insulia Diabetes Management CompanionVoluntis Sa.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200330
200510
200610
200810
201410
FIG. 1 — Lineage of K202596, 2001–2021Source: 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 NDC? 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 NDC device

  1. #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 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
*K172177Insulia Diabetes Management Companion
Summary page 4
…General Hospital 5.3 Predicate Device Trade Name: Insulia Diabetes Management Companion 510(k) Reference: K172177, concurrence received on November 7, 2017 Common Name:…
Voluntis Sa.20171

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 20 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 12 of the 17 ancestors have a recall of any class.

How does its category compare?

All NDC devices

NDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · NDC

2in 2025

2007: 12008: 22010: 12012: 22014: 32015: 32016: 22017: 82018: 32019: 12020: 52021: 32023: 32024: 32025: 22026 (partial year): 4
2007high 8 (2017) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDC

60in 2024

2014: 118 days median2015: 199 days median2017: 189 days median2018: 220 days median2020: 53 days median2021: 269 days median2023: 126 days median2024: 60 days median2026 (partial year): 90 days median
2007high 269 (2021) · low 53 (2020)2026

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

Recalls per year · NDC

1in 2025

2016: 12017: 22018: 12019: 12022: 12025: 12026 (partial year): 2
2007high 2 (2017) · low 0 (2007)2026

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

Adverse event reports per year · NDC

299in 2025

2008: 72009: 42010: 182011: 112012: 22013: 12014: 12015: 12016: 182017: 252018: 212019: 182020: 102021: 112022: 3472023: 4632024: 1682025: 299
2007high 463 (2023) · low 0 (2007)2025

MAUDE reports naming product code NDC, 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—00
20082—07
20090—04
20101—018
20110—011
20122—02
20130—01
2014311801
2015319901
20162—118
20178189225
20183220121
20191—118
2020553010
20213269011
20220—1347
202331260463
20243600168
20252—1299
20264902—

What is it indicated for?

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of…

Read the full statement (180 words)

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.

Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.

Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice.

Insulia Diabetes Management Companion includes software intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols.

Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Indications for use as stated in the FDA summary.

More from Voluntis Sa.

5 FDA decisions under this applicant name. See the company

  • K232451Insulia Bolus CompanionVoluntis Sa. · 2023
  • K172177Insulia Diabetes Management CompanionVoluntis Sa. · 20171 recall
  • K170669Insulia Diabetes Management CompanionVoluntis Sa. · 20171 recall
  • K161433Insulia Diabetes Management CompanionVoluntis Sa. · 2016

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https://510kreport.com/device/K202596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202596: Insulia Diabetes Management Companion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202596

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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