510(k) · Cleared
ClearedK-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
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 Jul 8, 2025 as substantially equivalent to K212095 (Terumo Europe N.V., 2022) after a 60-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Jul 8, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904198 (1990). 13 ancestors in all, the oldest K771205 (1977). No later device cites it as a predicate yet.
- Root · 8 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 7 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 6 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 5 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 4 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 3 generations backK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- 2 generations backK122249 Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012
- 1 generation backK212095 SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V. · 2022
- This deviceK251447 K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)Terumo Europe N.V. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −7 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −6 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −5 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −4 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −3 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| −2 | K122249 | Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety Needle | Terumo (Philippines) Corporation | 2012 | — |
| −1 | K212095 | SurGuard3 Safety Hypodermic Needle | Terumo Europe N.V. | 2022 | — |
| 0 (this device) | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K212095 | SurGuard3 Safety Hypodermic NeedleSummary page 5…Class II 3. Predicate Devices (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed: - SURGUARD3 SAFETY HYPODERMIC NEEDLE (K212095) manufactured by Terumo Europe N.V. 4. Reason for 510(k) Submission This premarket notification [510(k)] is being… | 2022 |
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 35 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 13 ancestors have a recall of any class.
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?
Intended Purpose: The K-Pack Embrace™ Active Safety Needle, being a hypodermic needle with safety shield, is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The safety shield shall be manually locked (activated), after use, to cover the needle to minimize the risk of accidental needle stick.
Indications: The K-Pack Embrace™ Active Safety Needle is for general application – for treatment (injection of fluids) or diagnosis (withdrawal of fluids).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251447 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251447: K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251447
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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