510(k) · Cleared
ClearedSterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Tech Co., Ltd. · QNQ Low Dead Space Piston Syringe
Cleared on Sep 19, 2022 as substantially equivalent to K192551 (Jiangsu Caina Medical Co.,Ltd, 2020) after a 364-day review. Its family tree reaches back 8 generations to 1977.
- Decided
- Sep 19, 2022
- Review
- 364 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. No later device cites it as a predicate yet.
- 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 deviceK213013 Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV…Jeil Tech Co., Ltd. · 2022
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) | K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | Jeil Tech Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Summary page 4…Class of device : Class II 7) Panel : General hospital 4. Predicate Devices Trade name: Safety Syringe With Permanently Attached Needle Premarket Notification: K192551 Manufacturer: Jiangsu Caina Medical Co., Ltd. 5. Device description A Disposable Syringe with Needle is a device intended… | 2020 |
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 45 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.
- 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. 2022, 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?
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE is intended for use by
health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the
surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213013: Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213013
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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