510(k) · Cleared
ClearedSedatelec Asp Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedatelec · MQX Needle, Acupuncture, Single Use
Cleared on Aug 27, 1999 as substantially equivalent to K970254 (Seirin-America, Inc., 1997) after a 303-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 27, 1999
- Review
- 303 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970254 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970254 Seirin Pyonex Acupuncture NeedlesSeirin-America, Inc. · 1997
- This deviceK983798 Sedatelec Asp Acupuncture NeedlesSedatelec · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970254 | Seirin Pyonex Acupuncture Needles | Seirin-America, Inc. | 1997 | — |
| 0 (this device) | K983798 | Sedatelec Asp Acupuncture Needles | Sedatelec | 1999 | — |
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 |
|---|---|---|---|
| * | K970254 | Seirin Pyonex Acupuncture NeedlesSummary page 2…n Table: Equivalency SEDATELEC SEIRIN-S Comparison ASP & ASP Gold acupuncture SEIRIN — PIONEX acupuncture needies Feature needles Device Type: Tack Tack 510(k) number | K970254 Intended use: Mmmmwhmmdambyqfifiedwamhmdawmmeas determined by the states Invasive Length (mm) 2.1mm From 15 to 50mm From 1.5to 1.8… | 1997 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K970254.
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.
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/K983798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983798: Sedatelec Asp 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/K983798
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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