510(k) · Cleared
ClearedAcuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K.S. Choi Corporation · MQX Needle, Acupuncture, Single Use
Cleared on Aug 25, 2015 as substantially equivalent to K031716 (Asia-Med GmbH and CO KG, 2003) and 1 other predicate after a 334-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Aug 25, 2015
- Review
- 334 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031716 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK031716 Special+, S-Needle J-Type, S-Needle B-TypeAsia-Med GmbH and CO KG · 2003
- This deviceK142760 Acuzone Acupuncture Needles, KSC DB Plus Acupuncture NeedlesK.S. Choi Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031716 | Special+, S-Needle J-Type, S-Needle B-Type | Asia-Med GmbH and CO KG | 2003 | — |
| 0 (this device) | K142760 | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | K.S. Choi Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K031716 | Special+, S-Needle J-Type, S-Needle B-TypeSummary page 4…Predicate Device: 807.92(a) The summary identifies the legally marketed device to which your firm is claiming equivalence: (1) Asia-med : Asia-med Special + Needle (K031716) and (K042063) Description of the Device 807.92(a) : The acupuncture needles are sterile, thin needles which are inserted into… | 2003 |
| * | K042063 | Press Tack NeedleSummary page 4…vice: 807.92(a) The summary identifies the legally marketed device to which your firm is claiming equivalence: (1) Asia-med : Asia-med Special + Needle (K031716) and (K042063) Description of the Device 807.92(a) : The acupuncture needles are sterile, thin needles which are inserted into specific point… | 2004 |
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. 2015, 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?
Our acupuncture needles are devices used by licensed practitioners and are intended 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/K142760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142760: Acuzone Acupuncture Needles, KSC DB Plus 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/K142760
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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