510(k) · Cleared
ClearedSinger Acupuncture Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lorac, Inc. · MQX Needle, Acupuncture, Single Use
Cleared on Feb 5, 1998 as substantially equivalent to K962809 (Seirin-America, Inc., 1996) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Feb 5, 1998
- Review
- 56 days
- Class
- Class II
- Product code
- MQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962809 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K090199Jiajian Acupuncture NeedleWuxi Jiajian Medical Instrument Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962809 | Seirin Acupuncture Needles | Seirin-America, Inc. | 1996 | — |
| 0 (this device) | K974616 | Singer Acupuncture Needles | Lorac, Inc. | 1998 | — |
| +1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K962809 | Seirin Acupuncture NeedlesSummary page 1…mon/Usual Name:, ACUPUNCTURE NEEDLE, SINGLE USE . Equivalent legally marketed devices: These products are similar in design and function to: Seirin Acupuncture needles, K962809 and Lhasa Acupuncture needles, K962916. . Indications for Use (intended use): To pierce the skin the practice of acupuncture by… | 1996 |
| * | K962916 | Hua-Xia Acupuncture NeedlesSummary page 1…GLE USE . Equivalent legally marketed devices: These products are similar in design and function to: Seirin Acupuncture needles, K962809 and Lhasa Acupuncture needles, K962916. . Indications for Use (intended use): To pierce the skin the practice of acupuncture by qualified practitioners as determined b… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090199 | Jiajian Acupuncture Needle | 2009 | 0 |
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?
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
of acupuncture 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/K974616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974616: Singer 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/K974616
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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