510(k) · Cleared

Recalled · Class II · 2017

Novopen Echo, a Dial a Dose Insulin Delivery Pen

K123766510(k) TraditionalCleared Aug 15, 2013251-day reviewClass II21 CFR 880.5860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Novo Nordisk, Inc. · FMF Syringe, Piston

Cleared on Aug 15, 2013 as substantially equivalent to K010359 (Novo Nordisk A/S, 2001) after a 251-day review. Its family tree reaches back 1 generation to 2001. 1 of the 30 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it. It has been recalled once.

Decided: Aug 15, 2013
Review: 251 days
Class: Class II
Product code: FMF
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K010359 (2001). 28 later devices descend from it, 3 citing it directly. 1 of the 30 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK010359 InnovoNovo Nordisk A/S · 2001
This deviceK123766 Novopen Echo, a Dial a Dose Insulin Delivery PenNovo Nordisk, Inc. · 2013
Descendant · cites it directly · 21 of its ownK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
Descendant · 2 generations on · 10 of its ownK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
Descendant · 3 generations on · 7 of its ownK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
Descendant · 4 generations on · 6 of its ownK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
Descendant · cites it directly · 5 of its ownK150874 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc. · 2015 · Recalled

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2015high 6 (2026) · low 0 (2017)2026

Class I recalls in this family

K193483 Basal-IQ Technology3 generations on · 2020

Most influential descendants

Showing 5 of 28 · See all

K160629InPenCompanion Medical, Inc. · 2016 · cites it directly21descendants
K190487InPen Dose CalculatorCompanion Medical, Inc. · 2020 · 2 generations on10descendants
K201337InPen SystemCompanion Medical, Inc. · 2020 · 3 generations on7descendants
K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · 4 generations on6descendants
K150874NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc. · 2015 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010359	Innovo	Novo Nordisk A/S	2001	—
0 (this device)	K123766	Novopen Echo, a Dial a Dose Insulin Delivery Pen	Novo Nordisk, Inc.	2013	—
+1	K160629	InPen	Companion Medical, Inc.	2016	1
+2	K190487	InPen Dose Calculator	Companion Medical, Inc.	2020	1
+3	K201337	InPen System	Companion Medical, Inc.	2020	2
+4	K242775	InPen System App (MMT-8060 (iOS), MMT-8061 (Android))	Medtronic Minimed	2024	3
+1	K150874	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)	Novo Nordisk, Inc.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	2	0
2018	2	0
2020	4	1
2022	2	0
2023	1	0
2024	5	0
2025	5	0
2026	6	0

FIG. 1 — Lineage of K123766, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K010359	Innovo	Novo Nordisk A/S	2001	—

Also cleared against K010359: 1 other device →

What descends from it? (28)

See all 28

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K160629	InPen	Companion Medical, Inc.	2016	21
K150874	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)	Novo Nordisk, Inc.	2015	5
K162602	NovoPen Echo	Novo Nordisk, Inc.	2016	4

Has anything in its family been recalled? (1 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.

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 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K160629 (Companion Medical, Inc., 2016) has gone furthest, with 21 descendants of its own.
1 other device also cites its predicate K010359.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)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-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill 3.0 mL cartridges of Novo Nordisk insulin 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 one-half (1/2) unit increments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123766 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123766: Novopen Echo, a Dial a Dose Insulin Delivery Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123766

Report an extraction error

Are you the manufacturer?

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