510(k) Report

510(k) · Cleared

Cleared

Humapen Memoir

K053563510(k) TraditionalCleared Apr 7, 2006107-day reviewClass II21 CFR 880.5860

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

Eli Lilly and Company · FMF Syringe, Piston

Cleared on Apr 7, 2006 as substantially equivalent to K010359 (Novo Nordisk A/S, 2001) after a 107-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.

Decided
Apr 7, 2006
Review
107 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010359 (2001). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2012: 1 descendant cleared2024: 2 descendants cleared2017: 1 descendant cleared2026: 1 descendant clearedK010359 · Innovo · Novo Nordisk A/S · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants K010359 · Innovo · Novo Nordisk A/S · 20010
  1. Root · 1 generation backK010359 InnovoNovo Nordisk A/S · 2001
  2. This deviceK053563 Humapen MemoirEli Lilly and Company · 2006
  3. Descendant · cites it directly · 6 of its ownK093065 Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc. · 2010
  4. Descendant · 2 generations on · 5 of its ownK100947 Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc. · 2010
  5. Descendant · 2 generations on · 4 of its ownK111924 Finesse Personal Insulin Delivery PatchCalibra Medical, Inc. · 2012
  6. Descendant · 3 generations on · 3 of its ownK163357 OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH · 2017
  7. Descendant · 3 generations on · 2 of its ownK233447 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 22012: 12017: 12024: 22026: 1
2010high 2 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all
  • K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc. · 2010 · cites it directly6descendants
  • K100947Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc. · 2010 · 2 generations on5descendants
  • K111924Finesse Personal Insulin Delivery PatchCalibra Medical, Inc. · 2012 · 2 generations on4descendants
  • K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH · 2017 · 3 generations on3descendants
  • K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010359InnovoNovo Nordisk A/S2001—
0 (this device)K053563Humapen MemoirEli Lilly and Company2006—
+1K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc.2010—
+2K100947Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc.2010—
+2K111924Finesse Personal Insulin Delivery PatchCalibra Medical, Inc.2012—
+3K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH2017—
+3K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201210
201710
202420
202610
FIG. 1 — Lineage of K053563, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K010359Innovo
Summary page 1
…ston Syringe 3. Predicate Device Manufacturer: Novo Nordisk Pharmaceuticals Proprietary Name: Innovo® Submission: K010359 4. Device Description HumaPen Memoir is a reusable mechanical pen-injector with electronic display designed for use for the self…
Novo Nordisk A/S2001—

Also cleared against K010359: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc.20106

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K093065 (Calibra Medical, Inc., 2010) has gone furthest, with 6 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.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
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

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

The HumaPen Memoir is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of insulin (Humalog® and Humulin®) and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose in one-unit increments up to 60 units.

Indications for use as stated in the FDA summary.

Also cleared against K010359

1 other device cites the same predicate.

  • K123766Novopen Echo, a Dial a Dose Insulin Delivery PenNovo Nordisk, Inc. · 20131 recall

More from Eli Lilly and Company

5 FDA decisions under this applicant name. See the company

  • K212217Tempo Smart ButtonEli Lilly and Company · 2022
  • K160949Go Dose SystemEli Lilly and Company · 2016
  • K142518HumaPen LuxuraEli Lilly and Company · 2015
  • K100988Humapen Luxura HDEli Lilly and Company · 2010

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K053563 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053563: Humapen Memoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053563

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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