510(k) · Cleared
Recalled · Class II · 2025InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · NDC Calculator, Drug Dose
Cleared on Nov 12, 2024 as substantially equivalent to K201337 (Companion Medical, Inc., 2020) after a 60-day review. Its family tree reaches back 10 generations to 2001. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 12, 2024
- Review
- 60 days
- Class
- Class II
- Product code
- NDC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010362 (2001). 18 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 6 generations between
- 3 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 2 generations backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- 1 generation backK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- This deviceK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024
- Descendant · cites it directly · 4 of its ownK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK253701 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
- Descendant · 3 generations on · 0 of its ownK261962 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
- Descendant · 2 generations on · 0 of its ownK253743 MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · Recalled
- Descendant · cites it directly · 0 of its ownK253470 MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit…Medtronic Minimed, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 9 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 8 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 7 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 6 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 5 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 4 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 3 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 2 generations backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- 1 generation backK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- This deviceK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · cites it directly4descendants
- K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026 · 2 generations on1descendant
- K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026 · 3 generations on0descendants
- K253743MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · 2 generations on0descendants
- K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −9 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −8 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −7 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −6 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −5 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −4 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −3 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −2 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| −1 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| 0 (this device) | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | — |
| +1 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| +2 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026 | — |
| +3 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026 | — |
| +2 | K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026 | 1 |
| +1 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | 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 |
|---|---|---|
| 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.
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 K260910 EndoTool IV Cloud 1.0score 14.9 · 13 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 |
|---|---|---|---|
| * | K201337 | InPen SystemSummary page 5…Pen Injector with Dose Calculator Predicate Device InPen™ System (MMT-8060/MMT-8061) Name and Model ID Predicate 510(k) K201337 Number Class II Classification Name Piston syringe with Drug Dose Calculator Product Code… | 2020 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2025 | Class II | Z-0958-2026 | Software Design Change | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and… |
| Jun 16, 2025 | Class II | Z-2496-2025 | Under Investigation by firm | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact… |
| 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.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 14 of the 18 ancestors have a recall of any class.
- Of its descendants, K251032 (Medtronic Minimed, Inc., 2025) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 System is a home-use reusable pen for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not…
Read the full statement (207 words)
The InPen System is a home-use reusable pen for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen Smart Insulin pen allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
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/K242775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242775
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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