510(k) · Cleared
Recalled · Class II · 2025InPen Dose Calculator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Companion Medical, Inc. · NDC Calculator, Drug Dose
Cleared on Feb 18, 2020 as substantially equivalent to K160629 (Companion Medical, Inc., 2016) after a 355-day review. Its family tree reaches back 8 generations to 2001. 1 of the 27 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once.
- Decided
- Feb 18, 2020
- Review
- 355 days
- Class
- Class II
- Product code
- NDC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010362 (2001). 16 ancestors in all. 10 later devices descend from it, 3 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 7 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 6 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 5 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 4 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 3 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 2 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 1 generation backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- This deviceK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020
- Descendant · cites it directly · 7 of its ownK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 6 of its ownK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- Descendant · 3 generations on · 4 of its ownK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- Descendant · 4 generations on · 1 of its ownK253701 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
- Descendant · 5 generations on · 0 of its ownK261962 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technologycites it directly · 2020
Most influential descendants
Showing 5 of 10 · See all- K201337InPen SystemCompanion Medical, Inc. · 2020 · cites it directly7descendants
- K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · 2 generations on6descendants
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · 3 generations on4descendants
- K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026 · 4 generations on1descendant
- K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −7 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −6 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −5 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −4 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −3 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −2 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −1 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| 0 (this device) | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | — |
| +1 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| +2 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | 3 |
| +3 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| +4 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026 | — |
| +5 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 1 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 0 |
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.
1 device in this family has a Class I recall. 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 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160629 | InPenSummary page 4…ulator Classification Name: Predictive pulmonary-function value calculator (21 CFR 868.1890); Class II Product Codes: NDC III. PREDICATE DEVICES InPen System (K160629) This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEV… | 2016 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2025 | Class II | Z-1650-2025 | Mixed-up of materials/components | Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen.… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 16 ancestors have a recall of any class.
- Of its descendants, K201337 (Companion Medical, Inc., 2020) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K160629.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NDC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDC
60in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDC
299in 2025
MAUDE reports naming product code NDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 3 | 118 | 0 | 1 |
| 2015 | 3 | 199 | 0 | 1 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 8 | 189 | 2 | 25 |
| 2018 | 3 | 220 | 1 | 21 |
| 2019 | 1 | — | 1 | 18 |
| 2020 | 5 | 53 | 0 | 10 |
| 2021 | 3 | 269 | 0 | 11 |
| 2022 | 0 | — | 1 | 347 |
| 2023 | 3 | 126 | 0 | 463 |
| 2024 | 3 | 60 | 0 | 168 |
| 2025 | 2 | — | 1 | 299 |
| 2026 | 4 | 90 | 2 | — |
What is it indicated for?
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. The device is indicated for use with NovoLog® or Humalog® U-100 insulin. For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate…
Read the full statement (110 words)
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.
For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190487: InPen Dose Calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190487
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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