510(k) · Cleared
ClearedK-Pack Surshield Needle, Hypodermic Needle for Single Use
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 6, 2011 as substantially equivalent to K050106 (Novo Nordisk, Inc., 2005) and 1 other predicate after a 102-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Jun 6, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904198 (1990). 13 ancestors in all, the oldest K771205 (1977). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 4 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 3 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 2 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 1 generation backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- This deviceK110527 K-Pack Surshield Needle, Hypodermic Needle for Single UseTerumo Europe N.V. · 2011
- Descendant · cites it directly · 2 of its ownK111797 27 G X 1/2 K-Pack Surshield NeedleTerumo Europe N.V. · 2011
- Descendant · 2 generations on · 0 of its ownK243309 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)Terumo Europe N.V. · 2025
- Descendant · 2 generations on · 0 of its ownK223353 DropSafeTM SicuraTMPikdare Spa · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −4 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −3 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −2 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −1 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| 0 (this device) | K110527 | K-Pack Surshield Needle, Hypodermic Needle for Single Use | Terumo Europe N.V. | 2011 | — |
| +1 | K111797 | 27 G X 1/2 K-Pack Surshield Needle | Terumo Europe N.V. | 2011 | — |
| +2 | K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025 | — |
| +2 | K223353 | DropSafeTM SicuraTM | Pikdare Spa | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K050106 | Novofine Autocover 30G X 8MMSummary page 2…cription/specifications, technology/principles of operation, materials and performance to the following cleared devices: I1.NovoFine" Autocover® 300 x 8 mm (K050 106) manufactured by Novo Nordisk inc., used as predicate for the sharps protection feature. 2. Terumo Surguard®2 S… | 2005 |
| * | K051865 | Terumo Surguard 2 Safety Needle or Similar | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111797 | 27 G X 1/2 K-Pack Surshield Needle | 2011 | 2 |
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 21 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K111797 (Terumo Europe N.V., 2011) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K050106.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SurshiedTM Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection as well as for injection in infusion lines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110527 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110527: K-Pack Surshield Needle, Hypodermic Needle for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110527
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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