510(k) · Cleared
ClearedNovofine 32G Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novo Nordisk, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 21, 2005 as substantially equivalent to K002403 (Novo Norodisk Pharmaceuticals, Inc., 2000) after a 7-day review. Its family tree reaches back 1 generation to 2000. 18 later devices descend from it.
- Decided
- Dec 21, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002403 (2000). 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002403 Novofine 31 Disposable NeedleNovo Norodisk Pharmaceuticals, Inc. · 2000
- This deviceK053470 Novofine 32G TipNovo Nordisk, Inc. · 2005
- Descendant · cites it directly · 17 of its ownK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
- Descendant · 2 generations on · 4 of its ownK093109 Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK133100 Carefine Pen NeedleFacet Technologies · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K062500Flexpen NeedleNovo Nordisk, Inc. · 2006 · cites it directly17descendants
- K090111Flexpen NeedleNovo Nordisk, Inc. · 2010 · cites it directly16descendants
- K113186Sterile Insulin Pen NeedleShina Corp. · 2012 · 2 generations on4descendants
- K093109Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010 · 2 generations on4descendants
- K133100Carefine Pen NeedleFacet Technologies · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002403 | Novofine 31 Disposable Needle | Novo Norodisk Pharmaceuticals, Inc. | 2000 | — |
| 0 (this device) | K053470 | Novofine 32G Tip | Novo Nordisk, Inc. | 2005 | — |
| +1 | K062500 | Flexpen Needle | Novo Nordisk, Inc. | 2006 | — |
| +1 | K090111 | Flexpen Needle | Novo Nordisk, Inc. | 2010 | — |
| +2 | K113186 | Sterile Insulin Pen Needle | Shina Corp. | 2012 | — |
| +2 | K093109 | Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5') | Novo Nordisk, Inc. | 2010 | — |
| +2 | K133100 | Carefine Pen Needle | Facet Technologies | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 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 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K002403 | Novofine 31 Disposable NeedleSummary page 1…Class II (3) SUBSTANTIAL EQU[VALENCE: The NovoFine ® 32(G Tip x 6 mm needle is substantially equivalent to the Novo Nordisk Novoline , 31G x 6 mm needle (K002403) which was cleared by FDA in l)ecember 2000. The term "substantial equivalence" as used in this 510(k) notification is limite… | 2000 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
NovoFine® 32G Tip needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053470: Novofine 32G Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053470
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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