510(k) · Cleared
ClearedK-Pack II Needle - 27G X 3/4 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 Sep 6, 2013 as substantially equivalent to K984576 (Terumo Europe N.V., 1999) and 2 other predicates after a 50-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Sep 6, 2013
- Review
- 50 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
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 deviceK132233 K-Pack II Needle - 27G X 3/4 Thin WallTerumo Europe N.V. · 2013
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) | 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 |
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? (3)
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 with the K-Pack 11 Needle - 270 x 1/4" Thin Wall. The 27 Gauge needle size was added to 510k K984576 t… | 1999 |
| * | K001572 | Neolus NeedleSummary page 1…submitted. The cannula wall of this 270 x '14" needle is thinner than what is cuirrently cleared for the 27 Gauge needle under the 510k K984576 and 510k K001572. The thinner needle isecleared for the 270 x /" needle uinder the 510k KI 10850. The '/4" needle length was cleared… | 2000 |
| * | K110850 | K-Pack II Needle- 27G & 30G Thin Wall | 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 36 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 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. 2013, 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 27G x 3/4" 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/K132233 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132233: K-Pack II Needle - 27G X 3/4 Thin Wall.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132233
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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