Atlas FDA

CAZ

155 FDA 510(k) clearances · Product code

108 daysmedian time to decision
272 days90th percentile
155clearances measured

FDA profile

Official device name
Anesthesia Conduction Kit
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5140
Medical specialty
Anesthesiology
Flags
Third-party review eligible
FDA definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Adverse events (MAUDE)
2021: 165 · 2022: 270 · 2023: 60 · 2024: 165 · 2025: 138 · 2026: 69
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Arrow 0.2 Micron Flat Filter, GVS (K222341)Arrow International, LLC2023-02-13
BD Epilor Syringe (K210983)Becton, Dickinson and Company2022-05-19
Plastic LOR Syringe (K201356)Jiangsu Caina Medical Co.,Ltd2021-02-12
E-Cath STIM acc. Tsui (K202699)PAJUNK GmbH Medizintechnologie2020-12-29
VPC (K190345)PAJUNK GmbH Medizintechnologie2019-05-16
Arrow Epidural Catheter Kit (K161075)Teleflexmedical, Inc.2016-10-04
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (K153652)Teleflex, Inc.2016-06-21
Arrow Epidural Catheter Kit (K143581)Teleflexmedical, Inc.2015-06-26
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (K122690)Arrow International, Inc.2012-12-21
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT (K110053)Smiths Medical Asd, Inc.2012-09-14
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER (K122027)Arrow International, Inc.2012-08-28
PERIFUSE CATHETER (K121525)Smiths Medical Asd, Inc.2012-08-02
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (K121403)Teleflex, Inc.2012-06-20
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER (K103658)Teleflex, Inc.2012-05-16
FENESTRATED NERVE BLOCK NEEDLE (K113662)Imd, Inc.2012-04-20
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG (K113188)PAJUNK GmbH Medizintechnologie2012-03-01
CONTIPLEX FX (K113059)B.Braun Medical, Inc.2012-01-24
ECHOBRIGHT (K111355)Life-Tech, Inc.2011-09-16
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, (K102007)Life-Tech, Inc.2010-12-22
ECHOBRIGHT (K093662)Life-Tech, Inc.2010-06-24
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E (K092657)Smiths Medical Asd, Inc.2009-11-04
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET (K090995)B.Braun Medical, Inc.2009-08-14
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF (K082183)PAJUNK GmbH Medizintechnologie2008-10-28
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT (K082164)PAJUNK GmbH Medizintechnologie2008-10-27
BUSSE PLASTIC LOR SYRINGE (K080804)Busse Hosipital Disposables2008-07-09
PERIPHERAL NERVE BLOCK SUPPORT TRAY (K073187)Life-Tech, Inc.2008-04-22
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET (K063282)B.Braun Medical, Inc.2007-06-20
PAJUNKS EPILONG SET PEDIATRIC (K062902)PAJUNK GmbH Medizintechnologie2007-06-07
GLASS LOSS OF RESISTANCE SYRINGE (K063018)Busse Hospital Disposables, Inc.2007-01-22
PAJUNKS STIMULONG TSUI-METHOD SET (K062900)PAJUNK GmbH Medizintechnologie2007-01-12
LOSS OF RESISTANCE SYRINGE (K061737)Robert Busse & Co., Inc.2006-12-18
POLYPLEX STIMULATING CATHETER SYSTEM (K060186)Te ME NA Sas2006-07-18
EPILONG KIT FOR ANESTHESIOLOGY (K060311)PAJUNK GmbH Medizintechnologie2006-06-13
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV (K060563)Pajunk GmbH2006-06-02
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET (K052954)Life-Tech, Inc.2006-02-15
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET (K053283)Pajunk GmbH2006-01-12
MPS ACACIA NERVE BLOCK NEEDLE (K052946)Mps Acacia2005-12-08
STINGRAY EPIDURAL CATHETER CONNECTOR (K051171)Epimed International, Inc.2005-08-26
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS (K043130)Pajunk GmbH2004-12-21
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (K041158)Atrion Medical Products, Inc.2004-06-16
STIMULONG PLUS CATHETER SET MODEL, VARIOUS (K033018)Pajunk GmbH2004-05-05
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER (K033080)Portex, Inc.2004-03-10
PERIFIX CATHETER CONNECTOR (K033952)B.Braun Medical, Inc.2004-02-04
B-SMART, MODEL B-01 (K031128)Macosta Medical USA, LLC2004-01-15
PERIFIX CATHETER CONNECTOR (K032144)B.Braun Medical, Inc.2003-10-01
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 (K022752)Hdc Corp.2003-09-09
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK (K030937)Arrow International, Inc.2003-04-23
AVID-NIT NERVE STIMULATION NEEDLES (K014246)Avid N.I.T., Inc.2002-07-16
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 (K021567)Arrow Intl., Inc.2002-06-19
PLEXOLONG SETS (K013041)Pajunk GmbH2002-06-11
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT (K012584)Bd2001-09-06
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 (K994059)Hdc Corp.2000-10-13
MICOR ANESTHESIA CONDUCTION KIT (K001940)Micor, Inc.2000-08-11
19 GA PLASTIC REINFORCED EPIDURAL CATHETER (K001587)Arrow Intl., Inc.2000-07-12
PROLONG, MODELS PL50, PL100, PL150 (K001129)Life-Tech Intl., Inc.2000-07-06
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS (K991719)Medimex Holfeld GmbH & Co.1999-08-18
EPIDURAL CATHETER MODELS 1210/1200 (K983125)Rusch Intl.1998-11-17
SOFT TIP EPIDURAL CATHETER KIT (K971233)B.Braun Medical, Inc.1997-10-17
PERIFIX PEDIATRIC EPIDURAL KIT (K962696)B.Braun Medical, Inc.1997-04-03
REGIONAL ANESTHESIA TRAYS (K965017)Smiths Industries Medical Systems, Inc.1997-03-14
EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT (K964783)Alexander Medical, Inc.1997-02-12
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (K962880)Sherwood Medical Co.1996-12-09
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT (K962821)Global Medical Products, Ltd.1996-11-13
MEDCARE REGIONAL ANETHESIA KIT (K961075)Medcare Medical Group, Inc.1996-09-06
MORE-L INJECTOR KIT PLUS (K960619)Incutech, Inc.1996-06-20
KENDALL BLUNT TUOHY EPIDURAL NEEDLE (K954706)Kendall Healthcare Products Co. Div.Of Tyco Health1996-05-30
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY (K954953)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-05-20
SPINAL SPECIALTIES NERVE BLOCK TRAY (K960100)Spinal Specialties, Inc.1996-04-24
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET (K954835)Holgrath Medical Technologies, Inc.1996-01-31
MORELL INJECTOR (K951870)Incutech, Inc.1996-01-22
BD PERISAFE EPIDURAL ANESTHESIA TRAY (K953790)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-11-30
KENDALL SAFETAP SPINAL ANESTHESIA TRAY (K953766)Kendall Healthcare Products Co. Div.Of Tyco Health1995-11-24
B-D SPINAL ANESTHESIA TRAY SPINAL (K953467)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-10-27
CONTINUOUS EPIDURAL ANESTHESIA TRAY (K944029)Spinal Specialties, Inc.1995-06-30
GERTIE MARX EPI-SPINAL TRAY (K943319)Spinal Specialties, Inc.1995-06-30
PIDURAL STEROID SYSTEM (K945484)Professional Medical Device Consultants1995-06-02
EPI-SPINAL ANESTHESIA TRAY (K941153)Preferred Medical Products1995-05-30
SENSI-TOUCH EPIDURAL ANESTHESIA TRAY (K950929)Sherwood Medical Co.1995-05-30
CONTINUOUS EPIDURAL ANESTHESIA TRAY (K945671)Trinity Laboratories, Inc.1995-02-16
B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT (K945497)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-02-13
REGIONAL ANAESTHESIA TRAY (K932614)Mediziv Medical Products , Ltd.1994-09-21
SPINAL ANESTHESIA TRAY (K941343)Spinal Specialties, Inc.1994-08-11
KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT (K941493)Kendall Healthcare Products Co. Div.Of Tyco Health1994-06-22
EPIDURAL ANESTHESIA TRAY (K935245)Spinal Specialties, Inc.1994-05-02
EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM (K933721)Neurodelivery Technology, Inc.1994-01-31
MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY (K934526)Neurodelivery Technology, Inc.1994-01-28
CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS (K931670)Carapace, Inc.1994-01-25
E-SP COMBINED EPIDURAL-SPINAL ANESTHESIA TRAY (K933711)Neurodelivery Technology, Inc.1993-11-22
DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA (K932249)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-08-27
ANAGO SPINAL ANESTHESIA TRAY (K930161)Anago, Inc.1993-07-06
VARIOUS ANESTHETIC KITS OR TRAYS (K924707)Specialty Medical Products Co.1993-06-17
E-SP COMBINED EPI SPINAL MINISET (K925014)Neuro Technology1993-04-19
CURITY PLASTIC LOSS OF RESISTANCE SYRINGE (K922162)Kendall Healthcare Products Co. Div.Of Tyco Health1993-04-07
ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT (K920615)Anago, Inc.1993-03-20
B-D LOSS OF RESISTANCE SYRINGE (K925902)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-01-14
MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT (K912445)Mega Medical, Inc.1991-10-18
MEGA SPINAL ANESTHESIA KIT (K912322)Mega Medical, Inc.1991-09-26
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS (K904440)Preferred Medical Products1991-06-07
CURITY SPINAL ANESTHESIA TRAY (K903761)Kendall Healthcare Products Co. Div.Of Tyco Health1990-12-19
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY (K904101)Kendall Healthcare Products Co. Div.Of Tyco Health1990-12-04
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