510(k) · Cleared
ClearedNipro Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 14, 2001 as substantially equivalent to K944355 (Nissho Corp., 1994) after a 73-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Dec 14, 2001
- Review
- 73 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944355 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- This deviceK013293 Nipro Hypodermic NeedleNipro Medical Corp. · 2001
- Descendant · cites it directly · 1 of its ownK021224 Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK052365 Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005
- Descendant · cites it directly · 0 of its ownK052551 Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002 · cites it directly1descendant
- K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005 · 2 generations on0descendants
- K052551Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| 0 (this device) | K013293 | Nipro Hypodermic Needle | Nipro Medical Corp. | 2001 | — |
| +1 | K021224 | Endocervical Block Needle | Wallach Surgical Devices, Inc. | 2002 | — |
| +2 | K052365 | Cervineedle Disposable Cartridge Syringe | Rocket Medical Plc | 2005 | — |
| +1 | K052551 | Devon Standard Syringe, Hypodermic Needle and Insulin Syringe | Devon Safety Products, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K944355 | Nipro Branded Disposable Syringes, NeedlesSummary page 1…& Lo Aol Contact Person: Eiji Shinozaki A/CFL eva 5570 Date of Summary Preparation: December .4, 2001 §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: K944355 Nipro Hypodermic Needle §807.92 (a)(4) Description of the Device: The devices that we intend to m ket are hypodermic needles a… | 1994 |
What descends from it? (3)
2 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?
The Nipro® Hypodermic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013293 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013293: Nipro Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013293
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026