510(k) · Cleared
ClearedWoojeon Acupuncture Needle (=Sera Acupuncture Needle)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Woojeon Company · MQX Needle, Acupuncture, Single Use
Cleared on Nov 4, 2011 as substantially equivalent to K052085 (Asia-Med GmbH and CO KG, 2005) after a 170-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Nov 4, 2011
- Review
- 170 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052085 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK052085 Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type…Asia-Med GmbH and CO KG · 2005
- This deviceK111392 Woojeon Acupuncture Needle (=Sera Acupuncture Needle)Woojeon Company · 2011
- Descendant · cites it directly · 1 of its ownK141473 SMC Acupuncture NeedleSmc Intl., Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK162566 AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView 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) | K111392 | Woojeon Acupuncture Needle (=Sera Acupuncture Needle) | Woojeon Company | 2011 | — |
| +1 | K141473 | SMC Acupuncture Needle | Smc Intl., Inc. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K052085 | Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture NeedlesSummary page 1…lass of device : Classli. 4. Predicate Devices WOOJEON ACUPUNCTURE NEEDLE is similar with the legally marketed ASIA-MED Single use, Acupuncture Needle to have K052085. 5. Description of the Device The our needles are sterile which are inserted into specific points on the skin, called "acupunctur… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141473 | SMC Acupuncture Needle | 2014 | 1 |
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?
How does its category compare?
All MQX devicesMQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
WOOJEON ACUPUNCTURE NEEDLES 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/K111392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111392: Woojeon Acupuncture Needle (=Sera 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/K111392
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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