510(k) · Cleared
ClearedJiajian Acupuncture Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuxi Jiajian Medical Instrument Co., Ltd. · MQX Needle, Acupuncture, Single Use
Cleared on Aug 11, 2009 as substantially equivalent to K983800 (Sedatelec, 1999) and 1 other predicate after a 196-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 11, 2009
- Review
- 196 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962809 (1996). 5 ancestors in all, the oldest K961339 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962809 | Seirin Acupuncture Needles | Seirin-America, Inc. | 1996 | — |
| −1 | K974616 | Singer Acupuncture Needles | Lorac, Inc. | 1998 | — |
| 0 (this device) | K090199 | Jiajian Acupuncture Needle | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K983800 | DN Acupunture NeedlesSummary page 2…lthcare.com accordance with Standard ISO 11737-1. Substantial Equivalence Infomration: 1) Predicate Device: 510(k) Number: K983800 Marketing clearance date: August 2 7 th, 1999 Product name: DN Acupuncture Needles Manufacturer: Bu… | 1999 |
| * | K974616 | Singer Acupuncture NeedlesSummary page 2…ng clearance date: August 2 7 th, 1999 Product name: DN Acupuncture Needles Manufacturer: Buckman Company, Inc. 5 10(k) Number: K974616 Marketing clearance date: February 5 th, 1998 Product name: Singer Acupuncture Needles Manufactuer:… | 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 13 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- None of the 5 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. 2009, 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?
Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090199: Jiajian 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/K090199
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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