510(k) · Cleared
ClearedSterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yangzhou Medline Industry, Co., Ltd. · MEG Syringe, Antistick
Cleared on Aug 2, 2017 as substantially equivalent to K113422 (Terumo (Philippines) Corporation, 2012) and 1 other predicate after a 152-day review. Its family tree reaches back 6 generations to 1977. 32 later devices descend from it.
- Decided
- Aug 2, 2017
- Review
- 152 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K771205 (1977). 17 ancestors in all. 32 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 5 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 4 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 3 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 2 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 1 generation backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- This deviceK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- Descendant · cites it directly · 14 of its ownK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · cites it directly · 7 of its ownK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
- Descendant · 2 generations on · 6 of its ownK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK221247 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK211329 Sterile Disposable Syringe with Saftey Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd · 2020 · cites it directly14descendants
- K193526Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020 · cites it directly7descendants
- K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021 · 2 generations on6descendants
- K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2022 · cites it directly3descendants
- K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −5 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −4 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −3 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −2 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −1 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| 0 (this device) | 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 | — |
| +1 | K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| +2 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | — |
| +1 | K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022 | — |
| +2 | K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 11 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 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? (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 |
|---|---|---|---|
| * | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleSummary page 8…6G, 27G, 28G, 29G, 30G 5. Identification of Predicate Device Predicate Device 1 510(k) Number: K113422 Product Name: TERUMO® SurGuard® 3 Safety Needle TERUMO® SurGuard® 3 Hypodermic Syringe with Safety N… | 2012 |
| * | K083514 | Terumo Syringe with/Without NeedleSummary page 8…t Name: TERUMO® SurGuard® 3 Safety Needle TERUMO® SurGuard® 3 Hypodermic Syringe with Safety Needle Predicate Device 2 510(k) Number: K083514 Product Name: TERUMO® Syringe with/without Needle 6. Non-Clinical Test Conclusion Non clinical tests were conduct… | 2009 |
What descends from it? (32)
See all 326 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety… | 2020 | 14 |
| K193526 | Syringe with safety needle, Safety needle | 2020 | 7 |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle… | 2022 | 3 |
| K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for… | 2022 | 1 |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use… | 2020 | 1 |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe… | 2019 | 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 40 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K192551 (Jiangsu Caina Medical Co.,Ltd, 2020) has gone furthest, with 14 descendants of its own.
- 7 other devices also cite its predicate K113422.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose. The…
Read the full statement (188 words)
The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.
The Sterile Disposable Syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Disposable Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170651
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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