510(k) · Cleared

Cleared

Safety Syringe

K053519510(k) TraditionalCleared Aug 11, 2006235-day reviewClass II21 CFR 880.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wuxi Yushou Medical Applicances Co., Ltd. · MEG Syringe, Antistick

Cleared on Aug 11, 2006 as substantially equivalent to K011103 (Bd, 2001) after a 235-day review. Its family tree reaches back 1 generation to 2001. 79 later devices descend from it.

Decided: Aug 11, 2006
Review: 235 days
Class: Class II
Product code: MEG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011103 (2001). 79 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011103 BD Spring Based SyringeBd · 2001
This deviceK053519 Safety SyringeWuxi Yushou Medical Applicances Co., Ltd. · 2006
Descendant · cites it directly · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
Descendant · 2 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
Descendant · 2 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
Descendant · 3 generations on · 13 of its ownK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019
Descendant · 2 generations on · 12 of its ownK180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic…Berpu Medical Technology Co., Ltd. · 2018

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2008high 15 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 79 · See all

K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · cites it directly78descendants
K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 2 generations on36descendants
K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 2 generations on31descendants
K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd. · 2019 · 3 generations on13descendants
K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Berpu Medical Technology Co., Ltd. · 2018 · 2 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011103	BD Spring Based Syringe	Bd	2001	—
0 (this device)	K053519	Safety Syringe	Wuxi Yushou Medical Applicances Co., Ltd.	2006	—
+1	K072739	Jierui Syringes and Needles	Shandong Weigao Group Medical Polymer Co., Ltd.	2008	—
+2	K110421	Disposable Insulin Syringe	Wenzhou Wuzhou Import & Export Co., Ltd.	2011	—
+2	K112057	KDL Syringes and Needle	Shanghai Kindly Enterprise Dev. Group Co.,	2011	—
+3	K190002	Sterile Hypodermic Syringe for Single use, with/without needle, Sterile…	Shanghai Kohope Medical Devices Co., Ltd.	2019	—
+2	K180417	Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes…	Berpu Medical Technology Co., Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	3	0
2012	1	0
2013	1	0
2015	1	0
2016	3	0
2017	4	0
2018	3	0
2019	2	0
2020	4	0
2021	13	0
2022	13	0
2023	15	0
2024	6	0
2025	6	0
2026	3	0

FIG. 1 — Lineage of K053519, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K011103	BD Spring Based Syringe Our reading of the summary gave K001103, FDA’s number for Wireless Ambulatory Eeg, Model EX-Amb-Wireless (Proposed) (Excel Tech., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BD Spring Based Syringe”.	Bd	2001	—

Also cleared against K011103: 3 other devices →

What descends from it? (79)

See all 79

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072739	Jierui Syringes and Needles	Shandong Weigao Group Medical Polymer Co., Ltd.	2008	78

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?

Its one ancestor has no recall.
Of its descendants, K072739 (Shandong Weigao Group Medical Polymer Co., Ltd., 2008) has gone furthest, with 78 descendants of its own.
3 other devices also cite its predicate K011103.

How does its category compare?

All MEG devices

MEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEG

1in 2025

2007high 13 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEG

229in 2023

2007high 296 (2020) · low 100 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MEG

1in 2024

2007high 5 (2013) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MEG

148in 2025

2007high 541 (2021) · low 20 (2008)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 device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin except for phlebotomy. 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053519 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053519: Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053519

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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