510(k) · Cleared
ClearedAIK Sterile Acupuncture Needles for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changchun Aik Medical Devices Co., Ltd. · MQX Needle, Acupuncture, Single Use
Cleared on May 11, 2017 as substantially equivalent to K141473 (Smc Intl., Inc., 2014) after a 239-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- May 11, 2017
- Review
- 239 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052085 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backK052085 Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type…Asia-Med GmbH and CO KG · 2005
- 2 generations backK111392 Woojeon Acupuncture Needle (=Sera Acupuncture Needle)Woojeon Company · 2011
- 1 generation backK141473 SMC Acupuncture NeedleSmc Intl., Inc. · 2014
- This deviceK162566 AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052085 | Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture… | Asia-Med GmbH and CO KG | 2005 | — |
| −2 | K111392 | Woojeon Acupuncture Needle (=Sera Acupuncture Needle) | Woojeon Company | 2011 | — |
| −1 | K141473 | SMC Acupuncture Needle | Smc Intl., Inc. | 2014 | — |
| 0 (this device) | K162566 | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | 2017 | — |
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 |
|---|---|---|---|
| * | K141473 | SMC Acupuncture NeedleSummary page 5…510(k) Code Number SMC Acupuncture SMC. MQX K141473 Needle 3. Indications for Use: The AIK Sterile Acupuncture Needles for Single Use is intended to pierce the skin in the… | 2014 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 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. 2017, 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 AIK Sterile Acupuncture Needles for Single Use 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/K162566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162566: AIK Sterile Acupuncture Needles for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162566
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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