510(k) · Cleared
ClearedCarbo/Optimed Brand Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Sen Sen Medical Supplies, Ltd. · MQX Needle, Acupuncture, Single Use
Cleared on Feb 21, 2003 as substantially equivalent to K003760 (Lhasa Medical, Inc., 2001) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 21, 2003
- Review
- 31 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961339 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK961339 Carbo Brand/Viva Brand Acupuncture NeedlesHelio Medical Supplies, Inc. · 1996
- 1 generation backK981272 Addiquip Disposable Acupuncture NeedlesElectro Therapeutic Devices, Inc. · 1998
- This deviceK030190 Carbo/Optimed Brand Acupuncture NeedlesSuzhou Sen Sen Medical Supplies, Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961339 | Carbo Brand/Viva Brand Acupuncture Needles | Helio Medical Supplies, Inc. | 1996 | — |
| −1 | K981272 | Addiquip Disposable Acupuncture Needles | Electro Therapeutic Devices, Inc. | 1998 | — |
| 0 (this device) | K030190 | Carbo/Optimed Brand Acupuncture Needles | Suzhou Sen Sen Medical Supplies, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K003760 | Tai-Chi Acupuncture NeedlesSummary page 1…the US market. It’s design and intended use is SE to the following brand of acupuncture needles available in the U S market: Tai-Chi Acupuncture needles (K003760) Addiquip Acupuncture needles (K.981272) ._ ..__. continued on next page _-… | 2001 |
| * | K981272 | Addiquip Disposable Acupuncture NeedlesSummary page 1…e following brand of acupuncture needles available in the U S market: Tai-Chi Acupuncture needles (K003760) Addiquip Acupuncture needles (K.981272) ._ ..__. continued on next page _- -… | 1998 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K003760.
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?
This device is intended to pierce 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/K030190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030190: Carbo/Optimed Brand 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/K030190
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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