510(k) Report

510(k) · Cleared

Cleared

Novofine 31 Disposable Needle

K002403510(k) TraditionalCleared Dec 8, 2000123-day reviewClass II21 CFR 880.5570

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

Novo Norodisk Pharmaceuticals, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Dec 8, 2000 after a 123-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.

Decided
Dec 8, 2000
Review
123 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
0

37 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2002: 1 descendant cleared2006: 1 descendant cleared2011: 2 descendants cleared2016: 2 descendants cleared2010: 2 descendants cleared2018: 1 descendant cleared2014: 4 descendants cleared2012: 2 descendants cleared2017: 2 descendants cleared2026: 3 descendants cleared2025: 2 descendants cleared2022: 2 descendants cleared2020: 3 descendants cleared2021: 4 descendants cleared2019: 1 descendant cleared2024: 1 descendant cleared2023: 2 descendants cleared200020052010201520202025
  1. This deviceK002403 Novofine 31 Disposable NeedleNovo Norodisk Pharmaceuticals, Inc. · 2000
  2. Descendant · cites it directly · 34 of its ownK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
  3. Descendant · cites it directly · 18 of its ownK053470 Novofine 32G TipNovo Nordisk, Inc. · 2005
  4. Descendant · 2 generations on · 17 of its ownK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
  5. Descendant · 2 generations on · 16 of its ownK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
  6. Descendant · 2 generations on · 11 of its ownK151311 Safe Block Pen NeedleArtsana S.P.A · 2016

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2002: 12005: 22006: 12010: 22011: 22012: 22014: 42016: 22017: 22018: 12019: 12020: 32021: 42022: 22023: 22024: 12025: 22026: 3
2002high 4 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 37 · See all
  • K050106Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005 · cites it directly34descendants
  • K053470Novofine 32G TipNovo Nordisk, Inc. · 2005 · cites it directly18descendants
  • K062500Flexpen NeedleNovo Nordisk, Inc. · 2006 · 2 generations on17descendants
  • K090111Flexpen NeedleNovo Nordisk, Inc. · 2010 · 2 generations on16descendants
  • K151311Safe Block Pen NeedleArtsana S.P.A · 2016 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002403Novofine 31 Disposable NeedleNovo Norodisk Pharmaceuticals, Inc.2000—
+1K050106Novofine Autocover 30G X 8MMNovo Nordisk, Inc.2005—
+1K053470Novofine 32G TipNovo Nordisk, Inc.2005—
+2K062500Flexpen NeedleNovo Nordisk, Inc.2006—
+2K090111Flexpen NeedleNovo Nordisk, Inc.2010—
+2K151311Safe Block Pen NeedleArtsana S.P.A2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200520
200610
201020
201120
201220
201440
201620
201720
201810
201910
202030
202140
202220
202320
202410
202520
202630
FIG. 1 — Lineage of K002403, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMI? 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 FMI device

  1. #1 K252886 Pen Needlescore 14.5 · 4 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K050106Novofine Autocover 30G X 8MMNovo Nordisk, Inc.200534
K053470Novofine 32G TipNovo Nordisk, Inc.200518
K021197Sureone Insulin Syringe, 31 Gauge X 5/16Hosuk Co., Ltd.20020

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?

  • Of its descendants, K050106 (Novo Nordisk, Inc., 2005) has gone furthest, with 34 descendants of its own.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

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https://510kreport.com/device/K002403 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002403: Novofine 31 Disposable Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002403

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026