510(k) · Cleared
ClearedK-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle (Hypodermic Needle) 25G X 1, Model KN-2525RB, K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Europe N.V. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 14, 1999 as substantially equivalent to K771203 (Terumo America, Inc., 1977) after a 173-day review. Its family tree reaches back 1 generation to 1977. 13 later devices descend from it.
- Decided
- Jun 14, 1999
- Review
- 173 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771203 (1977). 13 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- This deviceK984576 K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II…Terumo Europe N.V. · 1999
- Descendant · cites it directly · 10 of its ownK062608 29G and 30G K-Pack II NeedleTerumo Europe N.V. · 2006
- Descendant · cites it directly · 9 of its ownK082820 K-Pack II Needle - 29G Thin WallTerumo Europe N.V. · 2008
- Descendant · cites it directly · 5 of its ownK110850 K-Pack II Needle- 27G & 30G Thin WallTerumo Europe N.V. · 2011
- Descendant · cites it directly · 2 of its ownK192057 K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle -…Terumo Europe N.V. · 2019
- Descendant · 2 generations on · 1 of its ownK230951 Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K06260829G and 30G K-Pack II NeedleTerumo Europe N.V. · 2006 · cites it directly10descendants
- K082820K-Pack II Needle - 29G Thin WallTerumo Europe N.V. · 2008 · cites it directly9descendants
- K110850K-Pack II Needle- 27G & 30G Thin WallTerumo Europe N.V. · 2011 · cites it directly5descendants
- K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin…Terumo Europe N.V. · 2019 · cites it directly2descendants
- K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| 0 (this device) | K984576 | K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle… | Terumo Europe N.V. | 1999 | — |
| +1 | K062608 | 29G and 30G K-Pack II Needle | Terumo Europe N.V. | 2006 | — |
| +1 | K082820 | K-Pack II Needle - 29G Thin Wall | Terumo Europe N.V. | 2008 | — |
| +1 | K110850 | K-Pack II Needle- 27G & 30G Thin Wall | Terumo Europe N.V. | 2011 | — |
| +1 | K192057 | K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2”… | Terumo Europe N.V. | 2019 | — |
| +2 | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K771203 | Disp. Hypodermic NeedleSummary page 1…ivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Disposable Hypodermic Needle which is the subject of K771203. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness. INTENDED USE: Bot… | 1977 |
What descends from it? (13)
See all 138 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062608 | 29G and 30G K-Pack II Needle | 2006 | 10 |
| K082820 | K-Pack II Needle - 29G Thin Wall | 2008 | 9 |
| K110850 | K-Pack II Needle- 27G & 30G Thin Wall | 2011 | 5 |
| K192057 | K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin… | 2019 | 2 |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | 2015 | 0 |
| K150263 | K-Pack II Needle-21G x 2 | 2015 | 0 |
| K132233 | K-Pack II Needle - 27G X 3/4 Thin Wall | 2013 | 0 |
| K050505 | Depotone | 2005 | 0 |
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 K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use. intended 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/K984576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984576: K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle (Hypodermic Needle) 25G X 1, Model KN-2525RB, K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984576
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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