510(k) · Cleared
Recalled · Class II · 2025InPen System
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 Jun 18, 2020 as substantially equivalent to K190487 (Companion Medical, Inc., 2020) after a 29-day review. Its family tree reaches back 9 generations to 2001. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 18, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- NDC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010362 (2001). 17 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 5 generations between
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 1 generation backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- This deviceK201337 InPen SystemCompanion Medical, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- Descendant · 2 generations on · 4 of its ownK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- Descendant · 3 generations on · 1 of its ownK253701 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
- Descendant · 4 generations on · 0 of its ownK261962 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
- Descendant · 3 generations on · 0 of its ownK253743 MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · Recalled
Show all 9 generations
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 8 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 7 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 6 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 5 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 4 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 1 generation backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- This deviceK201337 InPen SystemCompanion Medical, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · cites it directly6descendants
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · 2 generations on4descendants
- K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026 · 3 generations on1descendant
- K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026 · 4 generations on0descendants
- K253743MiniMed Flex pumpMedtronic Minimed, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −8 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −7 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −6 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −5 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −4 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −3 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −2 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −1 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| 0 (this device) | K201337 | InPen System | Companion Medical, Inc. | 2020 | — |
| +1 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | 3 |
| +2 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| +3 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026 | — |
| +4 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026 | — |
| +3 | K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026 | 1 |
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 |
|---|---|---|
| 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.
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 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 |
|---|---|---|---|
| * | K190487 | InPen Dose CalculatorSummary page 4…tion Name: Piston Syringe Classification Regulation: 21 CFR 880.5860; Class II Product Codes: FMF, NDC III. PREDICATE DEVICES InPen™ System (K190487) This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEV… | 2020 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | 2024 | 6 |
Has anything in its family been recalled? (0 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.… |
| Nov 8, 2022 | Class II | Z-0741-2023 | Software design | Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or… |
No ancestor or descendant has a 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 1.3 years on median.
- 13 of the 17 ancestors have a recall of any class.
- Of its descendants, K242775 (Medtronic Minimed, 2024) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K190487.
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 is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 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 (205 words)
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 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 injector 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 age 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/K201337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201337: InPen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201337
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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