510(k) · Cleared
ClearedAddiquip Disposable Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro Therapeutic Devices, Inc. · MQX Needle, Acupuncture, Single Use
Cleared on Aug 24, 1998 as substantially equivalent to K961339 (Helio Medical Supplies, Inc., 1996) after a 139-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Aug 24, 1998
- Review
- 139 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961339 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK961339 Carbo Brand/Viva Brand Acupuncture NeedlesHelio Medical Supplies, Inc. · 1996
- This deviceK981272 Addiquip Disposable Acupuncture NeedlesElectro Therapeutic Devices, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK030190 Carbo/Optimed Brand Acupuncture NeedlesSuzhou Sen Sen Medical Supplies, Ltd. · 2003
Most influential descendants
Showing 1 of 1 · See all- K030190Carbo/Optimed Brand Acupuncture NeedlesSuzhou Sen Sen Medical Supplies, Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961339 | Carbo Brand/Viva Brand Acupuncture Needles | Helio Medical Supplies, Inc. | 1996 | — |
| 0 (this device) | K981272 | Addiquip Disposable Acupuncture Needles | Electro Therapeutic Devices, Inc. | 1998 | — |
| +1 | K030190 | Carbo/Optimed Brand Acupuncture Needles | Suzhou Sen Sen Medical Supplies, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K961339 | Carbo Brand/Viva Brand Acupuncture NeedlesSummary page 1…98. Manufacturer's Name & Address: (905) 475 8344. 905 475 5143. WU XIHOU ZHAI M.E. Factory, WUXT, JIANG SHU, China. Comparison to a legally marketed device: CARBO(k961339) acupuncture needles from China. Enclosed photocopy of their packaging. CARBO Stainless steel disposable acupuncture needles.… | 1996 |
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 |
|---|---|---|---|
| K030190 | Carbo/Optimed Brand Acupuncture Needles | 2003 | 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?
How does its category compare?
All MQX devicesMQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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/K981272 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981272: Addiquip Disposable Acupuncture Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981272
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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