510(k) · Cleared
Recalled · Class II · 2017NovoPen Echo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novo Nordisk, Inc. · FMF Syringe, Piston
Cleared on Oct 18, 2016 as substantially equivalent to K150874 (Novo Nordisk, Inc., 2015) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 18, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010359 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010359 InnovoNovo Nordisk A/S · 2001
- 2 generations backK123766 Novopen Echo, a Dial a Dose Insulin Delivery PenNovo Nordisk, Inc. · 2013 · Recalled
- 1 generation backK150874 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc. · 2015 · Recalled
- This deviceK162602 NovoPen EchoNovo Nordisk, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK182387 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK240961 Disposable Pen Injector AssemblyWuxi Nest Biotechnology Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK253747 Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK240774 Pen InjectorWuxi Nest Biotechnology Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc. · 2018 · cites it directly3descendants
- K240961Disposable Pen Injector AssemblyWuxi Nest Biotechnology Co., Ltd. · 2024 · 2 generations on1descendant
- K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K240774Pen InjectorWuxi Nest Biotechnology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010359 | Innovo | Novo Nordisk A/S | 2001 | — |
| −2 | K123766 | Novopen Echo, a Dial a Dose Insulin Delivery Pen | Novo Nordisk, Inc. | 2013 | 1 |
| −1 | K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | 2015 | 1 |
| 0 (this device) | K162602 | NovoPen Echo | Novo Nordisk, Inc. | 2016 | — |
| +1 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | 2018 | — |
| +2 | K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. | 2024 | — |
| +3 | K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026 | — |
| +2 | K240774 | Pen Injector | Wuxi Nest Biotechnology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 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 FMF? 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 16.1 · 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 |
|---|---|---|---|
| * | K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Summary page 4…tion: 21 CFR880.5860 Class: II Product Code: FMF Primary Predicate Device: K150874 NovoPen Echo ® Secondary Predicate Device: K123766 NovoPen Echo ® Device Description The NovoPen Echo® is a reusable… | 2015 |
| * | K123766 | Novopen Echo, a Dial a Dose Insulin Delivery PenSummary page 4…ass: II Product Code: FMF Primary Predicate Device: K150874 NovoPen Echo ® Secondary Predicate Device: K123766 NovoPen Echo ® Device Description The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 3… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 5, 2017 | Class II | Z-0206-2018 | Device Design | A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K182387 (Novo Nordisk, Inc., 2018) has gone furthest, with 3 descendants of its own.
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 NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162602: NovoPen Echo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162602
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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