510(k) · Cleared
ClearedK-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
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 Apr 4, 2025 as substantially equivalent to K110850 (Terumo Europe N.V., 2011) after a 141-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Apr 4, 2025
- Review
- 141 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K771203 (1977). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- 4 generations backK984576 K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II…Terumo Europe N.V. · 1999
- 3 generations backK062608 29G and 30G K-Pack II NeedleTerumo Europe N.V. · 2006
- 2 generations backK082820 K-Pack II Needle - 29G Thin WallTerumo Europe N.V. · 2008
- 1 generation backK110850 K-Pack II Needle- 27G & 30G Thin WallTerumo Europe N.V. · 2011
- This deviceK243581 K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)Terumo Europe N.V. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| −4 | K984576 | K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle… | Terumo Europe N.V. | 1999 | — |
| −3 | K062608 | 29G and 30G K-Pack II Needle | Terumo Europe N.V. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K110850 | K-Pack II Needle- 27G & 30G Thin WallSummary page 6…s II 3. Predicate Devices (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed: - K-Pack II Needle 27G x 1/2” Thin Wall (K110850) manufactured by Terumo Europe N.V. 4. Reason for 510(k) Submission This premarket notification [510(k)] is bein… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 48 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K110850.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 Enhance Needle a sterile, hypodermic needle, for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The K-Pack Enhance Needle is for general application - for injection of fluids or withdrawal of fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243581: K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243581
Report an extraction error
Are you the manufacturer?
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