510(k) · Cleared
ClearedSmall Volume 0.2mL Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosum Medical Limited · QNQ Low Dead Space Piston Syringe
Cleared on Apr 2, 2025 as substantially equivalent to K210443 (Poonglim Pharmatech, Inc., 2021) after a 75-day review. Its family tree reaches back 9 generations to 1977.
- Decided
- Apr 2, 2025
- Review
- 75 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. No later device cites it as a predicate yet.
- 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 backK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- This deviceK250138 Small Volume 0.2mL SyringeProsum Medical Limited · 2025
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 backK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- This deviceK250138 Small Volume 0.2mL SyringeProsum Medical Limited · 2025
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 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | — |
| 0 (this device) | K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K210443 | PLPT LDV (Low Dead Volume) Sterile SyringeSummary page 5…21 CFR 880.5860 Product code: QNQ Classification: Class II 4 Predicate Device Predicate device: K210443, PLPT LDV Sterile Syringe 5 Device Description The Small Volume 0.2mL Syringe is intended for manual, single use. It is a small… | 2021 |
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 48 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 23 ancestors have a recall of any class.
- 4 other devices also cite its predicate K210443.
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. 2025, 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?
The Small Volume 0.2mL Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250138: Small Volume 0.2mL Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250138
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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