510(k) · Cleared
ClearedHoly Dragon Brand Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wujiang City Hua Xin Medical Appliance Co., Ltd. · MQX Needle, Acupuncture, Single Use
Cleared on May 17, 2002 as substantially equivalent to K002910 (Anc Import & Export Co., Ltd., 2001) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 17, 2002
- Review
- 43 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002910 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK002910 Holy Dragon Acupuncture NeedlesAnc Import & Export Co., Ltd. · 2001
- This deviceK021095 Holy Dragon Brand Acupuncture NeedlesWujiang City Hua Xin Medical Appliance Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002910 | Holy Dragon Acupuncture Needles | Anc Import & Export Co., Ltd. | 2001 | — |
| 0 (this device) | K021095 | Holy Dragon Brand Acupuncture Needles | Wujiang City Hua Xin Medical Appliance Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 |
|---|---|---|---|
| * | K002910 | Holy Dragon Acupuncture NeedlesSummary page 1…, 1976. They are also equivalent to acupuncture needies which have been found to be substantially equivalent thfoug,h the 510(k) premarket process. These are Holy Dragon K002910 (2/7/2001) and Holy Dragon K011247 (10/17/2001). Waujiang City Hua Xin Medical Appliance Co., Ltd. 510(k) Submission Page?7 ===… | 2001 |
| * | K011247 | Holy Dragon Sterile Acupuncture Needle for Single UseSummary page 1…acupuncture needies which have been found to be substantially equivalent thfoug,h the 510(k) premarket process. These are Holy Dragon K002910 (2/7/2001) and Holy Dragon K011247 (10/17/2001). Waujiang City Hua Xin Medical Appliance Co., Ltd. 510(k) Submission Page?7 Description of Device:… | 2001 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All MQX devicesMQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
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/K021095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021095: Holy Dragon 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/K021095
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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