510(k) · Cleared
ClearedDBC Press Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lhasa Medical, Inc. · MQX Needle, Acupuncture, Single Use
Cleared on Jul 15, 2003 as substantially equivalent to K970254 (Seirin-America, Inc., 1997) after an 87-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jul 15, 2003
- Review
- 87 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 deviceK031250 DBC Press Acupuncture NeedlesLhasa Medical, Inc. · 2003
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) | K031250 | DBC Press Acupuncture Needles | Lhasa Medical, Inc. | 2003 | — |
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 1…hich have received approval through the 5 10(k) premarket notification process. These include the following: SEIRIN Pyonex Press Acupuncture Needles K-970254 ...... continued on next page LHASA MEDICAL,, INC. 234 Libbey Parkway, Weymouth, M A 0218… | 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?
These acupuncture needles are used to pierce the 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/K031250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031250: DBC Press Acupuncture Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031250
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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