510(k) · Cleared
ClearedCarbo Brand/Viva Brand Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helio Medical Supplies, Inc. · MQX Needle, Acupuncture, Single Use
Cleared on Jul 3, 1996 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jul 3, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK961339 Carbo Brand/Viva Brand Acupuncture NeedlesHelio Medical Supplies, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK052731 Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand…Daxin LI · 2006
- Descendant · cites it directly · 1 of its ownK983800 DN Acupunture NeedlesSedatelec · 1999
- Descendant · cites it directly · 1 of its ownK981272 Addiquip Disposable Acupuncture NeedlesElectro Therapeutic Devices, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK092240 Acupuncture NeedlesHaenglim Seowon Medical Co. · 2010
- Descendant · 2 generations on · 0 of its ownK090199 Jiajian Acupuncture NeedleWuxi Jiajian Medical Instrument Co., Ltd. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052731Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture NeedlesDaxin LI · 2006 · cites it directly1descendant
- K983800DN Acupunture NeedlesSedatelec · 1999 · cites it directly1descendant
- K981272Addiquip Disposable Acupuncture NeedlesElectro Therapeutic Devices, Inc. · 1998 · cites it directly1descendant
- K092240Acupuncture NeedlesHaenglim Seowon Medical Co. · 2010 · 2 generations on0descendants
- K090199Jiajian Acupuncture NeedleWuxi Jiajian Medical Instrument Co., Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961339 | Carbo Brand/Viva Brand Acupuncture Needles | Helio Medical Supplies, Inc. | 1996 | — |
| +1 | K052731 | Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles | Daxin LI | 2006 | — |
| +1 | K983800 | DN Acupunture Needles | Sedatelec | 1999 | — |
| +1 | K981272 | Addiquip Disposable Acupuncture Needles | Electro Therapeutic Devices, Inc. | 1998 | — |
| +2 | K092240 | Acupuncture Needles | Haenglim Seowon Medical Co. | 2010 | — |
| +2 | K090199 | Jiajian Acupuncture Needle | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K052731 (Daxin LI, 2006) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K961339 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961339: Carbo Brand/Viva Brand Acupuncture Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961339
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026