510(k) · Cleared
ClearedSTERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tsk Laboratory International Japan KK · QYM Ophthalmic Needle
Cleared on Oct 23, 2024 as substantially equivalent to K230951 (Terumo Europe N.V., 2023) after a 99-day review. Its family tree reaches back 7 generations to 1977.
- Decided
- Oct 23, 2024
- Review
- 99 days
- Class
- Class II
- Product code
- QYM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K771203 (1977). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- 6 generations backK984576 K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II…Terumo Europe N.V. · 1999
- 5 generations backK062608 29G and 30G K-Pack II NeedleTerumo Europe N.V. · 2006
- 4 generations backK082820 K-Pack II Needle - 29G Thin WallTerumo Europe N.V. · 2008
- 3 generations backK110850 K-Pack II Needle- 27G & 30G Thin WallTerumo Europe N.V. · 2011
- 2 generations backK192057 K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle -…Terumo Europe N.V. · 2019
- 1 generation backK230951 Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V. · 2023
- This deviceK242073 STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead…Tsk Laboratory International Japan KK · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| −6 | K984576 | K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle… | Terumo Europe N.V. | 1999 | — |
| −5 | K062608 | 29G and 30G K-Pack II Needle | Terumo Europe N.V. | 2006 | — |
| −4 | K082820 | K-Pack II Needle - 29G Thin Wall | Terumo Europe N.V. | 2008 | — |
| −3 | K110850 | K-Pack II Needle- 27G & 30G Thin Wall | Terumo Europe N.V. | 2011 | — |
| −2 | 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 | — |
| −1 | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. | 2023 | — |
| 0 (this device) | K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | Tsk Laboratory International Japan KK | 2024 | — |
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 QYM? 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 QYM device
- #1 K230951 Terumo Injection Filter Needle (NF-3013RBKE05M)score 10.7 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M)Summary page 5…Device Class: Class II 3. Legally Marketed Predicate Device Predicate # Predicate Trade Name Product Code K230951 Terumo Injection Filter Needle QYM Reference # Reference Device Trade Name… | 2023 |
| † | K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | 2024 |
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 47 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All QYM devicesQYM Ophthalmic Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QYM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QYM
Too few QYM 510(k)s in any year since 2007 to give a median.
Recalls per year · QYM
No recall names QYM since 2007.
Adverse event reports per year · QYM
9in 2025
MAUDE reports naming product code QYM, 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 | 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The device is intended to inject into or aspirate from, the body.
The device is intended for intravitreal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242073: STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242073
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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