510(k) · Cleared
ClearedK-Pack II Needle- 27G & 30G Thin Wall
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 9, 2011 as substantially equivalent to K984576 (Terumo Europe N.V., 1999) and 3 other predicates after a 73-day review. Its family tree reaches back 4 generations to 1977. 5 later devices descend from it.
- Decided
- Jun 9, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K771203 (1977). 7 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- 3 generations backK984576 K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II…Terumo Europe N.V. · 1999
- 2 generations backK062608 29G and 30G K-Pack II NeedleTerumo Europe N.V. · 2006
- 1 generation backK082820 K-Pack II Needle - 29G Thin WallTerumo Europe N.V. · 2008
- This deviceK110850 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
- Descendant · cites it directly · 0 of its ownK243581 K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)Terumo Europe N.V. · 2025
- Descendant · 3 generations on · 0 of its ownK242073 STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead…Tsk Laboratory International Japan KK · 2024
- Descendant · cites it directly · 0 of its ownK132233 K-Pack II Needle - 27G X 3/4 Thin WallTerumo Europe N.V. · 2013
Most influential descendants
Showing 5 of 5 · See all- 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
- K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)Terumo Europe N.V. · 2025 · cites it directly0descendants
- K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK · 2024 · 3 generations on0descendants
- K132233K-Pack II Needle - 27G X 3/4 Thin WallTerumo Europe N.V. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| −3 | K984576 | K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle… | Terumo Europe N.V. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +1 | K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025 | — |
| +3 | K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | Tsk Laboratory International Japan KK | 2024 | — |
| +1 | K132233 | K-Pack II Needle - 27G X 3/4 Thin Wall | Terumo Europe N.V. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K984576 | K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle (Hypodermic…Summary page 1…Section 880.5570 Classification: Class 11 11.2. Reason for Submission This 510k is being submitted to extend the cleared K-Pack 11 Needle (K984576) product line. The cannula wall of these 27G & 30G needles is thinner than what is currently cleared under the 51l0… | 1999 |
| * | K001572 | Neolus Needle | 2000 |
| * | K062608 | 29G and 30G K-Pack II NeedleSummary page 1…ula wall of these 27G & 30G needles is thinner than what is currently cleared under the 51l0k K984576 and 510k KOO01572 for the 27 Gauge needle and under the 510k K062608 for the 30 Gauge needle. Please note that the 27 Gauge needle size was added to 510k K984576 through internal… | 2006 |
| * | K082820 | K-Pack II Needle - 29G Thin WallSummary page 1…case instead of a long one as cleared under 510k K062608. The thinner needle and the shorter case were cleared for a 29 Gauge needle under the 510k K082820 and the shorter case was cleared for the 27 Gauge needle under the 510k K984576 (internal documentation). This Spec… | 2008 |
What descends from it? (5)
3 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?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K192057 (Terumo Europe N.V., 2019) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K984576.
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 270 & 30G Thin Wall K-Pack 11 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 as stated in the FDA summary.
https://510kreport.com/device/K110850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110850: K-Pack II Needle- 27G & 30G Thin Wall.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110850
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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