510(k) · Cleared

Cleared

Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles

K052731510(k) TraditionalCleared Feb 1, 2006125-day reviewClass II21 CFR 880.5580

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

Daxin LI · MQX Needle, Acupuncture, Single Use

Cleared on Feb 1, 2006 as substantially equivalent to K024207 (Helio Medical Supplies, Inc., 2003) and 2 other predicates after a 125-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Feb 1, 2006
Review: 125 days
Class: Class II
Product code: MQX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K961339 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK961339 Carbo Brand/Viva Brand Acupuncture NeedlesHelio Medical Supplies, Inc. · 1996
This deviceK052731 Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand…Daxin LI · 2006
Descendant · cites it directly · 0 of its ownK092240 Acupuncture NeedlesHaenglim Seowon Medical Co. · 2010

Most influential descendants

Showing 1 of 1 · See all

K092240Acupuncture NeedlesHaenglim Seowon Medical Co. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961339	Carbo Brand/Viva Brand Acupuncture Needles	Helio Medical Supplies, Inc.	1996	—
0 (this device)	K052731	Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles	Daxin LI	2006	—
+1	K092240	Acupuncture Needles	Haenglim Seowon Medical Co.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K052731, 1996–2010Source: 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 MQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K024207	Vinco Brand Acupuncture Needle Summary page 1 …Name: Acupuncture Needle Classification Name: Needle, Acupuncture, Single Use 3. Predicate Device Information: Vinco Brand Acupuncture Needle (K024207) Acumaster Band Acupuncture Needle (K99 I 508) Carbo Brand/Viva Brand Acu~puncture Needles (K(96 1339) 4. Devic…	Helio Medical Supplies, Inc.	2003	—
*	K991508	Acumaster Brand Acupuncture Needle	Helio Medical Supplies, Inc.	1999	—
*	K961339	Carbo Brand/Viva Brand Acupuncture Needles	Helio Medical Supplies, Inc.	1996	—

Also cleared against K024207: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K092240	Acupuncture Needles	Haenglim Seowon Medical Co.	2010	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?

None of the 3 ancestors has a recall.
Of its descendants, K092240 (Haenglim Seowon Medical Co., 2010) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K024207.

How does its category compare?

All MQX devices

MQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQX

1in 2017

2007high 3 (2015) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQX

245in 2015

2007high 245 (2015)2026

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

Recalls per year · MQX

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQX

2in 2025

2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code MQX, 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	1	—	1	0
2008	1	—	0	2
2009	2	—	0	0
2010	1	—	0	0
2011	2	—	0	0
2012	0	—	0	0
2013	1	—	0	1
2014	1	—	0	1
2015	3	245	0	1
2016	0	—	0	1
2017	1	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	1
2024	0	—	0	1
2025	0	—	0	2
2026	0	—	0	—

What is it indicated for?

The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052731 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052731: Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052731

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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