510(k) · Cleared
ClearedTerumo Injection Filter Needle (NF-3013RBKE05M)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Europe N.V. · QYM Ophthalmic Needle
Cleared on Oct 18, 2023 as substantially equivalent to K192057 (Terumo Europe N.V., 2019) after a 197-day review. Its family tree reaches back 6 generations to 1977. 1 later device descends from it.
- Decided
- Oct 18, 2023
- Review
- 197 days
- Class
- Class II
- Product code
- QYM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K771203 (1977). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- 5 generations backK984576 K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II…Terumo Europe N.V. · 1999
- 4 generations backK062608 29G and 30G K-Pack II NeedleTerumo Europe N.V. · 2006
- 3 generations backK082820 K-Pack II Needle - 29G Thin WallTerumo Europe N.V. · 2008
- 2 generations backK110850 K-Pack II Needle- 27G & 30G Thin WallTerumo Europe N.V. · 2011
- 1 generation backK192057 K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle -…Terumo Europe N.V. · 2019
- This deviceK230951 Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V. · 2023
- Descendant · cites it directly · 0 of its ownK242073 STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead…Tsk Laboratory International Japan KK · 2024
Most influential descendants
Showing 1 of 1 · See all- K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| −5 | K984576 | K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle… | Terumo Europe N.V. | 1999 | — |
| −4 | K062608 | 29G and 30G K-Pack II Needle | Terumo Europe N.V. | 2006 | — |
| −3 | K082820 | K-Pack II Needle - 29G Thin Wall | Terumo Europe N.V. | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 K242073 STERiJECT Ophthalmic Needle; STERiJECT…score 10.0 · 7 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 |
|---|---|---|---|
| * | K192057 | K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin…Summary page 6…al equivalence is claimed: - K-Pack II Needle 27G x 1/2” Extra Thin Wall, 27G x 1/2” Ultra Thin Wall, 30G x 1/2” Extra Thin Wall and 30G x 1/2” Ultra Thin Wall (K192057) manufactured by Terumo Europe N.V. 4. Reason for 510(k) Submission This premarket notification [510(k)] is being submi… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | 2024 | 0 |
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 46 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K242073 (Tsk Laboratory International Japan KK, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QYM devicesQYM Ophthalmic Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Terumo Injection Filter Needle is intended to inject fluids.
The Terumo Injection Filter Needle is indicated for general application - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230951: Terumo Injection Filter Needle (NF-3013RBKE05M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230951
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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