510(k) Report

510(k) · Cleared

Cleared

Jia Chen Acupuncture Needle, for Single Use

K023054510(k) TraditionalCleared Nov 13, 200261-day reviewClass II21 CFR 880.5580

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mandala Health Care, LLC · MQX Needle, Acupuncture, Single Use

Cleared on Nov 13, 2002 as substantially equivalent to K991507 (Helio Medical Supplies, Inc., 1999) and 2 other predicates after a 61-day review. Its family tree reaches back 1 generation to 1999.

Decided
Nov 13, 2002
Review
61 days
Class
Class II
Product code
MQX
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K991507 (1999). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestorsK991507 · Kangnian Brand Acupuncture Needle · Helio Medical Supplies, Inc. · 199919961998200020022004
Other ancestors, by generation 1 generation back: 2 other ancestors K991507 · Kangnian Brand Acupuncture Needle · Helio Medical Supplies, Inc. · 19990
  1. Root · 1 generation backK991507 Kangnian Brand Acupuncture NeedleHelio Medical Supplies, Inc. · 1999
  2. This deviceK023054 Jia Chen Acupuncture Needle, for Single UseMandala Health Care, LLC · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K991507Kangnian Brand Acupuncture NeedleHelio Medical Supplies, Inc.1999—
0 (this device)K023054Jia Chen Acupuncture Needle, for Single UseMandala Health Care, LLC2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
FIG. 1 — Lineage of K023054, 1999–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K991507Kangnian Brand Acupuncture Needle
Summary page 1
…ce, China Identification of predicate device(s): Kangnian Brand Acupuncture Needle, Single Use Manufactured by Suzhou Kangnian Medical Devices Co., Ltd. 510(k) Number: K991507 Spirit Brand Acupuncture Needle, Single Use Manufactured by Wujiang Acupuncture Needle Factory 510(k) Number: KO03010 Shen Ling…
Helio Medical Supplies, Inc.1999—
*K003010Spirit Acupuncture NeedleUnited Pacific Co., Ltd.2000—
*K002411Shenling Acupuncture NeedlesShenling Medical Device Co., Ltd.2000—

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 devices

MQX Needle, Acupuncture, Single Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQX

1in 2017

2007: 12008: 12009: 22010: 12011: 22013: 12014: 12015: 32017: 1
2007high 3 (2015) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQX

245in 2015

2015: 245 days median
2007high 245 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQX

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQX

2in 2025

2008: 22013: 12014: 12015: 12016: 12018: 12023: 12024: 12025: 2
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code MQX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—10
20081—02
20092—00
20101—00
20112—00
20120—00
20131—01
20141—01
2015324501
20160—01
20171—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—01
20240—01
20250—02
20260—0—

What is it indicated for?

Jia Chen Acupuncture Needie will be used for “Intended 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.

Recent decisions in MQX

The MQX category page

  • K162566AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd. · 2017
  • K142760Acuzone Acupuncture Needles, KSC DB Plus Acupuncture NeedlesK.S. Choi Corporation · 2015
  • K150903EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral…Maanshan Bond Medical Instruments Co., Ltd. · 2015
  • K142920KM Needles (Acupuncture Needle)K.M.S., Inc. · 2015
  • K141473SMC Acupuncture NeedleSmc Intl., Inc. · 2014

https://510kreport.com/device/K023054 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023054: Jia Chen Acupuncture Needle, for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023054

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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