Atlas FDA

MQX

91 FDA 510(k) clearances · Product code

83 daysmedian time to decision
232 days90th percentile
91clearances measured

FDA profile

Official device name
Needle, Acupuncture, Single Use
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5580
Medical specialty
General Hospital
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RecordFirmDate
AIK Sterile Acupuncture Needles for Single Use (K162566)Changchun Aik Medical Devices Co., Ltd.2017-05-11
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles (K142760)K.S. Choi Corporation2015-08-25
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural (K150903)Maanshan Bond Medical Instruments Co., Ltd.2015-07-15
KM Needles (Acupuncture Needle) (K142920)K.M.S., Inc.2015-06-10
SMC ACUPUNCTURE NEEDLE (K141473)Smc Intl., Inc.2014-08-01
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE (K132896)Asia-Med GmbH and CO KG2013-12-02
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) (K111392)Woojeon Company2011-11-04
BIOMATE STERILE ACUPUNCTURE NEEDLE (K103061)Biomate Medical Devices Technology Co., Ltd.2011-06-20
ACUPUNCTURE NEEDLES (K092240)Haenglim Seowon Medical Co.2010-04-21
JIAJIAN ACUPUNCTURE NEEDLE (K090199)Wuxi Jiajian Medical Instrument Co., Ltd.2009-08-11
HANSO ACUPUNCTURE NEEDLE (K090910)Hansol Medical Co.2009-06-30
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL (K071524)Tcm World, Inc.2008-04-10
BRIO ACUPUNCTURE NEEDLES (K072778)Helio Medical Supplies, Inc.2007-11-19
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES (K061517)Prime Herbs Corporation2006-11-22
LYRA ACUPUNCTURE NEEDLES (K062448)Helio Medical Supplies, Inc.2006-09-20
ASP TITANIUM (K060392)Sedatelec2006-04-26
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES (K052731)Daxin LI2006-02-01
SEVEN STAR NEEDLE (K052723)Helio Medical Supplies, Inc.2006-01-13
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE (K052846)Maanshan Medical Instruments Co., Ltd.2005-12-22
STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES (K052085)Asia-Med GmbH and CO KG2005-10-14
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES (K050295)Helio Medical Supplies, Inc.2005-03-25
ACUPUNCTURE NEEDLES (K043506)Marknew Products2005-02-11
C&G ACUPUNCTURE NEEDLE (K043277)Helio Medical Supplies, Inc.2005-02-08
ACUPUNCTURE NEEDLES (K041652)C.A.I. Industries Corp.2004-12-29
PRESS TACK NEEDLE (K042063)Asia-Med GmbH & Co. Kg. - Werk Suhl2004-10-14
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE (K031818)Facilai Enterprises , Ltd.2003-12-03
DBC PRESS ACUPUNCTURE NEEDLES (K031250)Lhasa Medical, Inc.2003-07-15
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES (K031060)Lhasa Medical, Inc.2003-07-11
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE (K031716)Asia-Med GmbH and CO KG2003-07-10
VINCO BRAND ACUPUNCTURE NEEDLE (K024207)Helio Medical Supplies, Inc.2003-04-14
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES (K030190)Suzhou Sen Sen Medical Supplies , Ltd.2003-02-21
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES (K023787)Lhasa Medical, Inc.2003-02-14
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE (K023054)Mandala Health Care, LLC2002-11-13
MAEDA SILVER ACUPUNCTURE NEEDLE (K021904)Maeda Toyokichi Shoten2002-08-14
QIZHOU ACUPUNCTURE NEEDLE (K013926)Wujiang City Shenli Medical and Health Material CO2002-07-18
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES (K020880)Marknew Products2002-06-10
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES (K021095)Wujiang City Hua Xin Medical Appliance Co., Ltd.2002-05-17
H.M.T. ACUPUNCTURE NEEDLE (K012501)Hummingbird Medical Technology, LLC2001-12-11
ACUGLIDE BRAND ACUPUNCTURE NEEDLES (K012583)Helio Medical Supplies, Inc.2001-12-11
CW DISPOSABLE ACUPUNCTURE NEEDLE (K011248)Acusupply, Inc.2001-10-29
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE (K011247)Acusupply, Inc.2001-10-17
HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE (K011242)Acusupply, Inc.2001-09-11
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) (K011808)Asia-Med GmbH and CO KG2001-07-10
BW ACUPUNCTURE NEEDLES (K011669)H F Intl. Co.2001-07-09
MAC ACUPUNCTURE NEEDLE (K002827)Haenglim Seowon Corp.2001-02-28
MAEDA NEW NEEDLE DISPOSABLE (K000581)Maeda Toyokichi Shoten2001-02-23
HOLY DRAGON ACUPUNCTURE NEEDLES (K002910)Anc Import & Export Co. , Ltd.2001-02-07
TAI-CHI ACUPUNCTURE NEEDLES (K003760)Lhasa Medical, Inc.2001-02-06
TIANXIE (K003748)Suzhou Tianyi Acupuncture Instruments Co., Ltd.2001-01-26
SHENLING ACUPUNCTURE NEEDLES (K002411)Shenling Medical Device Co., Ltd.2000-12-12
SPIRIT ACUPUNCTURE NEEDLE (K003010)United Pacific Co., Ltd.2000-10-19
MILLENNIA ACUPUNCTURE NEEDLE (K001718)United Pacific Co., Ltd.2000-06-21
SHARP BRAND ACUPUNCTURE NEEDLES (K000816)Tcm Supply Corp.2000-05-04
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S (K000740)Asahi Iryoki Co., Ltd.2000-04-12
SEDATELEC ASP ACUPUNCTURE NEEDLES (K983798)Sedatelec1999-08-27
ACUMASTER BRAND ACUPUNCTURE NEEDLE (K991508)Helio Medical Supplies, Inc.1999-08-27
KANGNIAN BRAND ACUPUNCTURE NEEDLE (K991507)Helio Medical Supplies, Inc.1999-08-27
DN ACUPUNTURE NEEDLES (K983800)Sedatelec1999-08-27
FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES (K990729)Acc Intl.1999-05-13
DBC, DONG BANG ACUPUNCTURE NEEDLES (K990328)Morning Star, Dong Bang Acupuncture U.S.A., Inc.1999-05-04
KINGLI ACUPUNCTURE NEEDLE (K990406)United Pacific Co., Ltd.1999-04-16
NATURAL BRAND ACUPUNCTURE NEEDLES (K983671)Tcm Supply Corp.1999-03-04
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES (K981272)Electro Therapeutic Devices, Inc.1998-08-24
JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID (K980899)Kenshin Trading Corp.1998-06-11
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE (K980472)American Institute of Koryo Hand Therapy1998-04-09
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE (K980471)American Institute of Koryo Hand Therapy1998-04-09
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE (K980470)American Institute of Koryo Hand Therapy1998-04-06
KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE (K980469)American Institute of Koryo Hand Therapy1998-04-03
SINGER ACUPUNCTURE NEEDLES (K974616)Lorac, Inc.1998-02-05
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA (K974122)Scientific Health Care1998-01-22
KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE (K974527)American Institute of Koryo Hand Therapy1998-01-13
DONG BANG ACUPUNCTURE NEEDLES (K972659)Dong Bang, U.S.A.1997-10-17
MAGI ACUPUNCTURE NEEDLES (K972658)Dong Bang, U.S.A.1997-10-17
ACUPUNCTURE NEEDLES (K964861)C.A.M. Supply, Inc.1997-05-29
ACUPUNCTURE NEEDLES (K970574)C.A.I. Industries Corp.1997-04-24
SEIRIN JR ACUPUNCTURE NEEDLES (K970260)Seirin-America, Inc.1997-02-10
SEIRIN PYONEX ACUPUNCTURE NEEDLES (K970254)Seirin-America, Inc.1997-02-10
CW ACUPUNCTURE NEEDLES (K964529)Lhasa Medical, Inc.1997-01-30
TAKI ACUPUNCTURE NEEDLES (K964411)Lhasa Medical, Inc.1996-12-31
NEEDLE, ACUPUNCTURE (K964051)S-Tcm Enterprises, Inc.1996-11-05
ACUPUNCTURE NEEDLES (K961677)K.S. Choi Corp.1996-10-28
SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES (K963769)Seirin-America, Inc.1996-10-16
HWA-TO ACUPUNCTURE NEEDLES (K963299)Lhasa Medical, Inc.1996-09-30
DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) (K963300)Lhasa Medical, Inc.1996-09-23
HUA-XIA ACUPUNCTURE NEEDLES (K962916)Lhasa Medical, Inc.1996-08-23
ITO ACUPUNCTURE NEEDLES (K963194)Oms Medical Supplies, Inc.1996-08-23
SEIRIN ACUPUNCTURE NEEDLES (K962809)Seirin-America, Inc.1996-08-16
TAKI DISPOSABLE ACUPUNCTURE NEEDLE (K962787)Acupuncture Supplies Import Co.1996-07-26
CW-DISPOSABLE ACUPUNCTURE NEEDLE (K962419)Acupuncture Supplies Import Co.1996-07-25
ACUPUNCTURE NEEDLE PACK (K960769)Acu-Med, Inc.1996-07-10
CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES (K961339)Helio Medical Supplies, Inc.1996-07-03

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Every clearance here is in the API, with alerts when new ones post.