510(k) · Cleared
ClearedHanso Acupuncture Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansol Medical Co. · MQX Needle, Acupuncture, Single Use
Cleared on Jun 30, 2009 as substantially equivalent to K052085 (Asia-Med GmbH and CO KG, 2005) after a 90-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Jun 30, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052085 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK052085 Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type…Asia-Med GmbH and CO KG · 2005
- This deviceK090910 Hanso Acupuncture NeedleHansol Medical Co. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052085 | Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture… | Asia-Med GmbH and CO KG | 2005 | — |
| 0 (this device) | K090910 | Hanso Acupuncture Needle | Hansol Medical Co. | 2009 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K052085 | Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture NeedlesSummary page 1…JUN 3 0 2009 2. The legally marketed device to which we are. claiming equivalence: ASIA-MED Single use, Acupuncture Needle. K052085 3. Description of device: Hansol Acupuncture Needle consists of components commonly found on Single use, Acupuncture Needle.… | 2005 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K052085.
How does its category compare?
All MQX devicesMQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090910: Hanso Acupuncture Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090910
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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