510(k) · Cleared
ClearedPLPT LDV (Low Dead Volume) Sterile Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poonglim Pharmatech, Inc. · QNQ Low Dead Space Piston Syringe
Cleared on Feb 16, 2021 as substantially equivalent to K192551 (Jiangsu Caina Medical Co.,Ltd, 2020) after a 0-day review. Its family tree reaches back 8 generations to 1977. 6 later devices descend from it.
- Decided
- Feb 16, 2021
- Review
- 0 days
- Class
- Class II
- Product code
- QNQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K771205 (1977). 22 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 7 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 6 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 5 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 4 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 3 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 2 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 1 generation backK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- This deviceK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK221860 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV…Poonglim Pharmatech, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250127 TSK SyringeTsk Laboratory, Japan · 2025
- Descendant · cites it directly · 0 of its ownK250138 Small Volume 0.2mL SyringeProsum Medical Limited · 2025
- Descendant · 2 generations on · 0 of its ownK241190 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV…Poonglim Pharmatech, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231165 Shina Syringe; Shina Safety SyringeShina Med Corporation · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2023 · cites it directly1descendant
- K250127TSK SyringeTsk Laboratory, Japan · 2025 · cites it directly0descendants
- K250138Small Volume 0.2mL SyringeProsum Medical Limited · 2025 · cites it directly0descendants
- K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2024 · 2 generations on0descendants
- K231165Shina Syringe; Shina Safety SyringeShina Med Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −7 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −6 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −5 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −4 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −3 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −2 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −1 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| 0 (this device) | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | — |
| +1 | K221860 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2023 | — |
| +1 | K250127 | TSK Syringe | Tsk Laboratory, Japan | 2025 | — |
| +1 | K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | 2025 | — |
| +2 | K241190 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2024 | — |
| +1 | K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 K242291 SOL-M Luer Lock Syringe (Low Dead Space) w/o…score 16.2 · 7 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 |
|---|---|---|---|
| * | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Summary page 4…Regulation Number: 21 CFR 880.5860 Product Code: QNQ Device Class: Class II Predicate Device: K192551, 1ml Luer Slip or Luer Lock Syringe Device Description A sterile device consisting of a calibrated barrel (cylinder) with plunge… | 2020 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 44 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K221860 (Poonglim Pharmatech, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K192551.
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. 2021, 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?
PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210443: PLPT LDV (Low Dead Volume) Sterile Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210443
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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