510(k) · Cleared
ClearedEZ-Injec LDV Sterile Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poonglim Pharmatech, Inc. · QNS Low Dead Space Needle, Single Lumen, Hypodermic
Cleared on Feb 16, 2021 as substantially equivalent to K192222 (Poonglim Pharmatech, Inc., 2020) after a 0-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.
- Decided
- Feb 16, 2021
- Review
- 0 days
- Class
- Class II
- Product code
- QNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944355 (1994). 6 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 4 generations backK052474 Nipro Hypodermic NeedleNipro Medical Corp. · 2005
- 3 generations backK102584 Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · Recalled
- 2 generations backK172483 Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018
- 1 generation backK192222 EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020
- This deviceK210444 EZ-Injec LDV Sterile Safety NeedlePoonglim 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 ownK250284 TSK SELECT™ NeedleTsk Laboratory, Japan · 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 ownK231734 STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK · 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
- K250284TSK SELECT™ NeedleTsk Laboratory, Japan · 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
- K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK · 2024 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −5 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −4 | K052474 | Nipro Hypodermic Needle | Nipro Medical Corp. | 2005 | — |
| −3 | K102584 | Imc Hypodermic Needle | International Medsurg Connection | 2011 | 20 |
| −2 | K172483 | Kopac Sterile Needle | Poonglim Pharmatech, Inc. | 2018 | — |
| −1 | K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | 2020 | — |
| 0 (this device) | K210444 | EZ-Injec LDV Sterile Safety Needle | 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 | K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025 | — |
| +2 | K241190 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2024 | — |
| +1 | K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | Tsk Laboratory International Japan KK | 2024 | — |
| +1 | K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 QNS? 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 QNS device
- #1 K242956 LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS…score 10.0 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K192222 | EZ-Inject Single use NeedleSummary page 4…Needle Regulation Number: 21 CFR 880.5570 Product Code: QNS Device Class: Class II Predicate Device: K192222, EZ-Injec Single Use Needle Device Description Sterile single use needle is a device intended to inject fluids into, or withdra… | 2020 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221860 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL… | 2023 | 1 |
| K250284 | TSK SELECT™ Needle | 2025 | 0 |
| K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | 2024 | 0 |
| K231165 | Shina Syringe; Shina Safety Syringe | 2023 | 0 |
| K220083 | LDV ((Low Dead Volume )Syringe | 2022 | 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 27 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K221860 (Poonglim Pharmatech, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QNS devicesQNS Low Dead Space Needle, Single Lumen, Hypodermic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QNS
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QNS
Too few QNS 510(k)s in any year since 2007 to give a median.
Recalls per year · QNS
No recall names QNS since 2007.
Adverse event reports per year · QNS
No MAUDE report names QNS since 2007.
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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This product is intended for use to inject fluid into or withdraw fluids from parts of the body below the surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210444: EZ-Injec LDV Sterile Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210444
Report an extraction error
Are you the manufacturer?
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