Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MQX — Predicate Candidate Screening
91 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
232 days90th percentile
91clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162566 | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | 2017-05-11 | 239 | 0 |
| K142760 | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | K.S. Choi Corporation | 2015-08-25 | 334 | 0 |
| K150903 | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIM | Maanshan Bond Medical Instruments Co., Ltd. | 2015-07-15 | 103 | 0 |
| K142920 | KM Needles (Acupuncture Needle) | K.M.S., Inc. | 2015-06-10 | 245 | 0 |
| K141473 | SMC ACUPUNCTURE NEEDLE | Smc Intl., Inc. | 2014-08-01 | 59 | 0 |
| K132896 | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HAND | Asia-Med GmbH and CO KG | 2013-12-02 | 77 | 0 |
| K111392 | WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) | Woojeon Company | 2011-11-04 | 170 | 0 |
| K103061 | BIOMATE STERILE ACUPUNCTURE NEEDLE | Biomate Medical Devices Technology Co., Ltd. | 2011-06-20 | 245 | 0 |
| K092240 | ACUPUNCTURE NEEDLES | Haenglim Seowon Medical Co. | 2010-04-21 | 272 | 0 |
| K090199 | JIAJIAN ACUPUNCTURE NEEDLE | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009-08-11 | 196 | 0 |
| K090910 | HANSO ACUPUNCTURE NEEDLE | Hansol Medical Co. | 2009-06-30 | 90 | 0 |
| K071524 | TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL | Tcm World, Inc. | 2008-04-10 | 311 | 0 |
| K072778 | BRIO ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | 2007-11-19 | 52 | 0 |
| K061517 | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE | Prime Herbs Corporation | 2006-11-22 | 174 | 0 |
| K062448 | LYRA ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | 2006-09-20 | 29 | 0 |
| K060392 | ASP TITANIUM | Sedatelec | 2006-04-26 | 70 | 0 |
| K052731 | KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND | Daxin LI | 2006-02-01 | 125 | 0 |
| K052723 | SEVEN STAR NEEDLE | Helio Medical Supplies, Inc. | 2006-01-13 | 106 | 0 |
| K052846 | TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDL | Maanshan Medical Instruments Co., Ltd. | 2005-12-22 | 76 | 0 |
| K052085 | STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TY | Asia-Med GmbH and CO KG | 2005-10-14 | 73 | 0 |
| K050295 | PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | 2005-03-25 | 46 | 0 |
| K043506 | ACUPUNCTURE NEEDLES | Marknew Products | 2005-02-11 | 53 | 0 |
| K043277 | C&G ACUPUNCTURE NEEDLE | Helio Medical Supplies, Inc. | 2005-02-08 | 74 | 0 |
| K041652 | ACUPUNCTURE NEEDLES | C.A.I. Industries Corp. | 2004-12-29 | 195 | 0 |
| K042063 | PRESS TACK NEEDLE | Asia-Med GmbH & Co. Kg. - Werk Suhl | 2004-10-14 | 73 | 0 |
| K031818 | FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE | Facilai Enterprises , Ltd. | 2003-12-03 | 174 | 0 |
| K031250 | DBC PRESS ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-07-15 | 87 | 0 |
| K031060 | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-07-11 | 99 | 0 |
| K031716 | SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE | Asia-Med GmbH and CO KG | 2003-07-10 | 37 | 0 |
| K024207 | VINCO BRAND ACUPUNCTURE NEEDLE | Helio Medical Supplies, Inc. | 2003-04-14 | 115 | 0 |
| K030190 | CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES | Suzhou Sen Sen Medical Supplies , Ltd. | 2003-02-21 | 31 | 0 |
| K023787 | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-02-14 | 93 | 0 |
| K023054 | JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE | Mandala Health Care, LLC | 2002-11-13 | 61 | 0 |
| K021904 | MAEDA SILVER ACUPUNCTURE NEEDLE | Maeda Toyokichi Shoten | 2002-08-14 | 65 | 0 |
| K013926 | QIZHOU ACUPUNCTURE NEEDLE | Wujiang City Shenli Medical and Health Material CO | 2002-07-18 | 232 | 0 |
| K020880 | MARKNEW PRODUCTS ACUPUNCTURE NEEDLES | Marknew Products | 2002-06-10 | 84 | 0 |
| K021095 | HOLY DRAGON BRAND ACUPUNCTURE NEEDLES | Wujiang City Hua Xin Medical Appliance Co., Ltd. | 2002-05-17 | 43 | 0 |
| K012501 | H.M.T. ACUPUNCTURE NEEDLE | Hummingbird Medical Technology, LLC | 2001-12-11 | 130 | 0 |
| K012583 | ACUGLIDE BRAND ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | 2001-12-11 | 123 | 0 |
| K011248 | CW DISPOSABLE ACUPUNCTURE NEEDLE | Acusupply, Inc. | 2001-10-29 | 189 | 0 |
| K011247 | HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE | Acusupply, Inc. | 2001-10-17 | 177 | 0 |
| K011242 | HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FO | Acusupply, Inc. | 2001-09-11 | 141 | 0 |
| K011808 | ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, A | Asia-Med GmbH and CO KG | 2001-07-10 | 29 | 0 |
| K011669 | BW ACUPUNCTURE NEEDLES | H F Intl. Co. | 2001-07-09 | 40 | 0 |
| K002827 | MAC ACUPUNCTURE NEEDLE | Haenglim Seowon Corp. | 2001-02-28 | 170 | 0 |
| K000581 | MAEDA NEW NEEDLE DISPOSABLE | Maeda Toyokichi Shoten | 2001-02-23 | 367 | 0 |
| K002910 | HOLY DRAGON ACUPUNCTURE NEEDLES | Anc Import & Export Co. , Ltd. | 2001-02-07 | 142 | 0 |
| K003760 | TAI-CHI ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2001-02-06 | 62 | 0 |
| K003748 | TIANXIE | Suzhou Tianyi Acupuncture Instruments Co., Ltd. | 2001-01-26 | 53 | 0 |
| K002411 | SHENLING ACUPUNCTURE NEEDLES | Shenling Medical Device Co., Ltd. | 2000-12-12 | 127 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda