510(k) · Cleared
ClearedSMC Acupuncture Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smc Intl., Inc. · MQX Needle, Acupuncture, Single Use
Cleared on Aug 1, 2014 as substantially equivalent to K111392 (Woojeon Company, 2011) after a 59-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Aug 1, 2014
- Review
- 59 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052085 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK052085 Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type…Asia-Med GmbH and CO KG · 2005
- 1 generation backK111392 Woojeon Acupuncture Needle (=Sera Acupuncture Needle)Woojeon Company · 2011
- This deviceK141473 SMC Acupuncture NeedleSmc Intl., Inc. · 2014
- Descendant · cites it directly · 0 of its ownK162566 AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162566AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052085 | Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture… | Asia-Med GmbH and CO KG | 2005 | — |
| −1 | K111392 | Woojeon Acupuncture Needle (=Sera Acupuncture Needle) | Woojeon Company | 2011 | — |
| 0 (this device) | K141473 | SMC Acupuncture Needle | Smc Intl., Inc. | 2014 | — |
| +1 | K162566 | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K111392 | Woojeon Acupuncture Needle (=Sera Acupuncture Needle)Summary page 5…807.92(a)(3) The summary identifies the legally marketed device to which your firm is claiming equivalence; (1) Woojeon Co. WOOJEON ACUPUNCTURE NEEDLE - K111392 K141473 page 2of3 Description o… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162566 | AIK Sterile Acupuncture Needles for Single Use | 2017 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162566 (Changchun Aik Medical Devices Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQX devicesMQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
SMC ACUPUNCTURE NEEDLE 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/K141473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141473: SMC 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/K141473
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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