510(k) · Cleared
ClearedSTERiJECT Low Dead Space, STERiJECT The Invisible Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tsk Laboratory International Japan KK · QNS Low Dead Space Needle, Single Lumen, Hypodermic
Cleared on Mar 8, 2024 as substantially equivalent to K210444 (Poonglim Pharmatech, Inc., 2021) and 1 other predicate after a 268-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Mar 8, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- QNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K944355 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 5 generations backK052474 Nipro Hypodermic NeedleNipro Medical Corp. · 2005
- 4 generations backK102584 Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · Recalled
- 3 generations backK172483 Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018
- 2 generations backK192222 EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020
- 1 generation backK210444 EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021
- This deviceK231734 STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −5 | K052474 | Nipro Hypodermic Needle | Nipro Medical Corp. | 2005 | — |
| −4 | K102584 | Imc Hypodermic Needle | International Medsurg Connection | 2011 | 20 |
| −3 | K172483 | Kopac Sterile Needle | Poonglim Pharmatech, Inc. | 2018 | — |
| −2 | K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | 2020 | — |
| −1 | K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | 2021 | — |
| 0 (this device) | K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | Tsk Laboratory International Japan KK | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 QNS? 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 QNS device
- #1 K210444 EZ-Injec LDV Sterile Safety Needlescore 17.1 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K210444 | EZ-Injec LDV Sterile Safety NeedleSummary page 4…Device Class: Class II 3. Legally Marketed Predicate Device Predicate # Predicate Trade Name Product Code K210444 EZ‐Injec LDV Sterile Safety Needle QNS Reference # Reference Device Trade Nam… | 2021 |
| * | K970370 | TSK Sterijekt Premium Disposable Hypodermic NeedleSummary page 4…‐Injec LDV Sterile Safety Needle QNS Reference # Reference Device Trade Name Product Code K970370 TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE FMI 4. Device Description Summary A lo… | 1997 |
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 30 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 4 other devices also cite its predicate K210444.
How does its category compare?
All QNS devicesQNS Low Dead Space Needle, Single Lumen, Hypodermic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QNS
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QNS
Too few QNS 510(k)s in any year since 2007 to give a median.
Recalls per year · QNS
No recall names QNS since 2007.
Adverse event reports per year · QNS
No MAUDE report names QNS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended to inject into or aspirate from, the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231734: STERiJECT Low Dead Space, STERiJECT The Invisible Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231734
Report an extraction error
Are you the manufacturer?
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