510(k) · Cleared
Cleared1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · MEG Syringe, Antistick
Cleared on Aug 10, 2020 as substantially equivalent to K170651 (Yangzhou Medline Industry, Co., Ltd., 2017) and 1 other predicate after a 328-day review. Its family tree reaches back 7 generations to 1977. 14 later devices descend from it.
- Decided
- Aug 10, 2020
- Review
- 328 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K771205 (1977). 21 ancestors in all. 14 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 6 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 5 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 4 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 3 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 2 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 1 generation backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- This deviceK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · cites it directly · 6 of its ownK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK213010 FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK231856 TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334…Medexel Co.,Ltd · 2024
- Descendant · 2 generations on · 1 of its ownK221860 PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV…Poonglim Pharmatech, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe…CMT Health PTE., Ltd. · 2026
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021 · cites it directly6descendants
- K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023 · cites it directly2descendants
- K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd · 2024 · 2 generations on1descendant
- K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc. · 2023 · 2 generations on1descendant
- K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −6 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −5 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −4 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −3 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −2 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −1 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| 0 (this device) | 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 | — |
| +1 | K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023 | — |
| +2 | K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | 2024 | — |
| +2 | K221860 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead… | Poonglim Pharmatech, Inc. | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 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 MEG? 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 MEG device
- #1 K252098 PA3X Detachable Safety Sleeve Syringe (with…score 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Summary page 7…n the sterility of the device during the shelf life of five years. 5. Identification of Predicate Devices 5.1 Predicate device 1 510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe wi… | 2017 |
| * | K132681 | Sol-Guard Insulin and Tuberculin Safety SyringeSummary page 7…Sterile Disposable Needle Manufacturer: Yangzhou Medline Industry Co., Ltd. 5.2 Predicate device 2 510(k) Number: K132681 Product Name: Sol-Guard Insulin Safety Syringe and Tuberculin Safety Syringe Manufacturer: Sol-Millennium M… | 2014 |
| † | K150758 | Safelock Disposable Insulin Syringe | 2015 |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | 2021 | 6 |
| K213010 | FEELject LDV (Low dead volume) syringe | 2023 | 2 |
| K221308 | Disposable Syringe with permanently attached needle, Safety Syringe with permanently… | 2022 | 0 |
| K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | 2022 | 0 |
| K213158 | Syringe with permanently attached needle | 2022 | 0 |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently… | 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 43 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K210443 (Poonglim Pharmatech, Inc., 2021) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K170651.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and 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. The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface…
Read the full statement (134 words)
1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and 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.
The Syringe with permanently attached needle 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.
The Safety Syringe with permanently attached needle 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. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192551
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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