510(k) · Cleared
ClearedJin Acupuncture Needles, Models ST, GL, SI, PT, and ID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kenshin Trading Corp. · MQX Needle, Acupuncture, Single Use
Cleared on Jun 11, 1998 as substantially equivalent to K963194 (Oms Medical Supplies, Inc., 1996) and 2 other predicates after a 93-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 11, 1998
- Review
- 93 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K961339 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961339 Carbo Brand/Viva Brand Acupuncture NeedlesHelio Medical Supplies, Inc. · 1996
- This deviceK980899 Jin Acupuncture Needles, Models ST, GL, SI, PT, and IDKenshin Trading Corp. · 1998
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) | K980899 | Jin Acupuncture Needles, Models ST, GL, SI, PT, and ID | Kenshin Trading Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K963194 | Ito Acupuncture NeedlesSummary page 1…e: MQX Panel Code: General Hospital Identification of the legally marketed device to which the submitter claims equivalence: ‘ 510(k) Number Trade Name Manufacturer 1) K963194 ITO Ito Co. (Japan) 2) K962809 SEIRIN Seirin Kasei (Japan) 3) K961339 CARBO Dynasty Medical (China) Description of the Device:… | 1996 |
| * | K962809 | Seirin Acupuncture NeedlesSummary page 1…pital Identification of the legally marketed device to which the submitter claims equivalence: ‘ 510(k) Number Trade Name Manufacturer 1) K963194 ITO Ito Co. (Japan) 2) K962809 SEIRIN Seirin Kasei (Japan) 3) K961339 CARBO Dynasty Medical (China) Description of the Device: JIN acupuncture needles are EtO… | 1996 |
| * | K961339 | Carbo Brand/Viva Brand Acupuncture NeedlesSummary page 1…rketed device to which the submitter claims equivalence: ‘ 510(k) Number Trade Name Manufacturer 1) K963194 ITO Ito Co. (Japan) 2) K962809 SEIRIN Seirin Kasei (Japan) 3) K961339 CARBO Dynasty Medical (China) Description of the Device: JIN acupuncture needles are EtO sterilized, surgical grade stainless s… | 1996 |
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?
- None of the 3 ancestors has a recall.
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 as determined by the States. The device is intended for single use only.
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/K980899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980899: Jin Acupuncture Needles, Models ST, GL, SI, PT, and ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980899
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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