510(k) · Cleared
ClearedAcupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haenglim Seowon Medical Co. · MQX Needle, Acupuncture, Single Use
Cleared on Apr 21, 2010 as substantially equivalent to K972659 (Dong Bang, U.S.A., 1997) and 2 other predicates after a 272-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Apr 21, 2010
- Review
- 272 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961339 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961339 | Carbo Brand/Viva Brand Acupuncture Needles | Helio Medical Supplies, Inc. | 1996 | — |
| −1 | K052731 | Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles | Daxin LI | 2006 | — |
| 0 (this device) | K092240 | Acupuncture Needles | Haenglim Seowon Medical Co. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 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
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 | Decided |
|---|---|---|---|
| * | K972659 | Dong Bang Acupuncture NeedlesSummary page 1…is substantially equivalent to the following devices: 510(k) Device Applicant Number K972659 Dong Bang Acupuncture Needle Dong Bang, U.S.A. C & G Acupuncture Ne… | 1997 |
| * | K043277 | C&G Acupuncture NeedleSummary page 1…K972659 Dong Bang Acupuncture Needle Dong Bang, U.S.A. C & G Acupuncture Needle K043277 Helio Medical Supplies, C& G Acupuncture Needle… | 2005 |
| * | K052731 | Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture NeedlesSummary page 1…K043277 Incorporated Kangsheng Brand/Kangnian Brand/Unilink Daxin Li K052731 Brand /Huazhong Brand Acupuncture Needle C/o… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K972659.
How does its category compare?
All MQX devicesMQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MQX
245in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQX
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQX
2in 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/K092240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092240: 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/K092240
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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