510(k) · Cleared
Recalled · 2011TSK Sterijekt Premium Disposable Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tsk Laboratory, Japan · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 10, 1997 after a 69-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled once.
- Decided
- Apr 10, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK970370 TSK Sterijekt Premium Disposable Hypodermic NeedleTsk Laboratory, Japan · 1997
- Descendant · cites it directly · 6 of its ownK151571 Mini NeedleOcujet, LLC · 2015
- Descendant · 2 generations on · 5 of its ownK170768 Mini NeedleOcuject, LLC · 2017
- Descendant · 3 generations on · 4 of its ownK183016 SteriCap Mini NeedleOcujet, LLC · 2019
- Descendant · 4 generations on · 3 of its ownK212805 SteriCap Mini Needle and Standard NeedlesOcuject, LLC · 2021
- Descendant · 5 generations on · 2 of its ownK230959 VitreJect® Needle; OcuSafe® NeedleOcuject, LLC · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151571Mini NeedleOcujet, LLC · 2015 · cites it directly6descendants
- K170768Mini NeedleOcuject, LLC · 2017 · 2 generations on5descendants
- K183016SteriCap Mini NeedleOcujet, LLC · 2019 · 3 generations on4descendants
- K212805SteriCap Mini Needle and Standard NeedlesOcuject, LLC · 2021 · 4 generations on3descendants
- K230959VitreJect® Needle; OcuSafe® NeedleOcuject, LLC · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970370 | TSK Sterijekt Premium Disposable Hypodermic Needle | Tsk Laboratory, Japan | 1997 | — |
| +1 | K151571 | Mini Needle | Ocujet, LLC | 2015 | — |
| +2 | K170768 | Mini Needle | Ocuject, LLC | 2017 | — |
| +3 | K183016 | SteriCap Mini Needle | Ocujet, LLC | 2019 | — |
| +4 | K212805 | SteriCap Mini Needle and Standard Needles | Ocuject, LLC | 2021 | — |
| +5 | K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | — | Becton Dickinson & Company B-D PrecisionGlide needles Named without a submission number |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2011 | Not classified | Z-0694-2012 | Packaging process control | Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151571 (Ocujet, LLC, 2015) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970370 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970370: TSK Sterijekt Premium Disposable Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970370
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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