510(k) · Cleared
ClearedSelf-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Berpu Medical Technology Co., Ltd. · MEG Syringe, Antistick
Cleared on Aug 9, 2018 as substantially equivalent to K072739 (Shandong Weigao Group Medical Polymer Co., Ltd., 2008) and 1 other predicate after a 175-day review. Its family tree reaches back 6 generations to 1990. 12 later devices descend from it.
- Decided
- Aug 9, 2018
- Review
- 175 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K904198 (1990). 31 ancestors in all, the oldest K771205 (1977). 12 later devices descend from it, 8 citing it directly.
- Root · 6 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 5 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 4 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 3 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 2 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 1 generation backK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- This deviceK180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic…Berpu Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 4 of its ownK211214 Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK223334 Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK221079 Sterile Hypodermic Syringes for Single UseSichuan Prius Biotechnology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK252631 Profoject™ Disposable NeedleCMT Health PTE., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242099 Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe…Sol-Millennium Medical, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K211214Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc. · 2021 · cites it directly4descendants
- K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd. · 2022 · 2 generations on1descendant
- K221079Sterile Hypodermic Syringes for Single UseSichuan Prius Biotechnology Co., Ltd. · 2022 · cites it directly1descendant
- K252631Profoject™ Disposable NeedleCMT Health PTE., Ltd. · 2025 · 2 generations on0descendants
- K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −5 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −4 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −3 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −2 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −1 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| 0 (this device) | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes… | Berpu Medical Technology Co., Ltd. | 2018 | — |
| +1 | K211214 | Sterile Hypodermic Needles for Single Use | Azur Medical Company, Inc. | 2021 | — |
| +2 | K223334 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Devices Co., Ltd. | 2022 | — |
| +1 | K221079 | Sterile Hypodermic Syringes for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022 | — |
| +2 | K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025 | — |
| +2 | K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without… | Sol-Millennium Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 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 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 |
|---|---|---|---|
| * | K072739 | Jierui Syringes and NeedlesSummary page 6…posed device is available in 14-30 gauge and 6-60 mm lengths. 5. Identification of Predicate and Reference Devices Predicate Device 1 510(k) Number: K072739 Product Name: Retractable Auto-Disable Syringe for Single Use, with/without Needle Sterile Hypodermic N… | 2008 |
| * | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleSummary page 6…Sterile Hypodermic Needle for Single Use Sterile Hypodermic Syringe for Single Use with/without Needle Predicate Device 2 510(k) Number: K113422 Product Name: TERUMO® SurGuard® 3 Safety Needle Reference Device 510(k) Number: K162180 Product Name: Dispo… | 2012 |
| † | K162180 | Disposable Insulin Syringe | 2016 |
What descends from it? (12)
See all 128 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211214 | Sterile Hypodermic Needles for Single Use | 2021 | 4 |
| K221079 | Sterile Hypodermic Syringes for Single Use | 2022 | 1 |
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single… | 2024 | 0 |
| K233037 | Sterile Hypodermic Needles for Single Use | 2023 | 0 |
| K231720 | Sterile Hypodermic Needles for Single Use | 2023 | 0 |
| K221066 | Sterile Hypodermic Needles for Single Use | 2022 | 0 |
| K221080 | Sterile Safety Hypodermic Needles for Single Use | 2022 | 0 |
| K210232 | Sterile Hypodermic Needles for Single Use | 2021 | 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 28 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 6 of the 31 ancestors have a recall of any class.
- Of its descendants, K211214 (Azur Medical Company, Inc., 2021) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K072739.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries. The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body. The…
Read the full statement (161 words)
The Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180417 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180417
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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