510(k) · Cleared
ClearedTopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medexel Co.,Ltd · QNQ Low Dead Space Piston Syringe
Cleared on Mar 15, 2024 as substantially equivalent to K213010 (Feeltech Co., Ltd., 2023) after a 266-day review. Its family tree reaches back 9 generations to 1977. 1 later device descends from it.
- Decided
- Mar 15, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- QNQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K771205 (1977). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 5 generations between
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK213010 FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023
- This deviceK231856 TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334…Medexel Co.,Ltd · 2024
- Descendant · cites it directly · 0 of its ownK252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe…CMT Health PTE., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 8 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 7 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 6 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 5 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 4 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK213010 FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023
- This deviceK231856 TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334…Medexel Co.,Ltd · 2024
Most influential descendants
Showing 1 of 1 · See all- K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −8 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −7 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −6 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −5 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −4 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −3 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −2 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| −1 | K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023 | — |
| 0 (this device) | K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | 2024 | — |
| +1 | K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 QNQ? 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 QNQ device
- #1 K210443 PLPT LDV (Low Dead Volume) Sterile Syringescore 18.0 · 8 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 |
|---|---|---|---|
| * | K213010 | FEELject LDV (Low dead volume) syringeSummary page 5…Regulation Number 21 CFR 880.5860 Product Code QNQ III. Legally Marketed Predicate Device Predicate # K213010 Predicate Trade Name FEELject LDV (Low dead volume) syringe IV. Device Description The TopFine® LDS (L… | 2023 |
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 |
|---|---|---|---|
| K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead… | 2026 | 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 47 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K252814 (CMT Health PTE., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QNQ devicesQNQ Low Dead Space Piston Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QNQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNQ
182in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QNQ
No recall names QNQ since 2007.
Adverse event reports per year · QNQ
3in 2025
MAUDE reports naming product code QNQ, 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 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 182 | 0 | 0 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231856: TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231856
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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