510(k) · Cleared
Recalled · Class II · 2025InPen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Companion Medical, Inc. · FMF Syringe, Piston
Cleared on Jul 26, 2016 as substantially equivalent to K123766 (Novo Nordisk, Inc., 2013) and 1 other predicate after a 141-day review. Its family tree reaches back 7 generations to 2001. 1 of the 37 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it. It has been recalled once.
- Decided
- Jul 26, 2016
- Review
- 141 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010362 (2001). 15 ancestors in all. 21 later devices descend from it, 5 citing it directly. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 6 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 5 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 4 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 3 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 2 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 1 generation backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- This deviceK160629 InPenCompanion Medical, Inc. · 2016
- Descendant · cites it directly · 10 of its ownK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 7 of its ownK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 6 of its ownK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- Descendant · 4 generations on · 4 of its ownK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- Descendant · cites it directly · 4 of its ownK222689 Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production · 2022
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology2 generations on · 2020
Most influential descendants
Showing 5 of 21 · See all- K190487InPen Dose CalculatorCompanion Medical, Inc. · 2020 · cites it directly10descendants
- K201337InPen SystemCompanion Medical, Inc. · 2020 · 2 generations on7descendants
- K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · 3 generations on6descendants
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · 4 generations on4descendants
- K222689Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production · 2022 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −6 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −5 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −4 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −3 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −2 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −1 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| 0 (this device) | K160629 | InPen | Companion Medical, Inc. | 2016 | — |
| +1 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| +2 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| +3 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | 3 |
| +4 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| +1 | K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | 2022 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 4 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K123766 | Novopen Echo, a Dial a Dose Insulin Delivery PenSummary page 4…ation Name: Piston Syringe Classification Regulation: (21 CFR §880.5860); Class II Product code: FMF, NDC III. PREDICATE DEVICES NovoPen® Echo (K123766) ACCU-CHEK® Bolus Advisor (K150910) These predicates have not been subject to a design-related recall. No reference devices were… | 2013 |
| * | K150910 | ACCU-CHEK Connect Diabetes Management AppSummary page 4…assification Regulation: (21 CFR §880.5860); Class II Product code: FMF, NDC III. PREDICATE DEVICES NovoPen® Echo (K123766) ACCU-CHEK® Bolus Advisor (K150910) These predicates have not been subject to a design-related recall. No reference devices were used in this submission. IV.… | 2015 |
What descends from it? (21)
See all 215 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 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 15 ancestors have a recall of any class.
- Of its descendants, K190487 (Companion Medical, Inc., 2020) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K123766.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 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 of insulin 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 is a home-use…
Read the full statement (208 words)
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 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 of insulin 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 is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Novo Nordisk Novolog® U-100 3.0 mL cartridges of insulin 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 age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160629: InPen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160629
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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