Atlas FDA

BSO

75 FDA 510(k) clearances · Product code

144 daysmedian time to decision
282 days90th percentile
75clearances measured

FDA profile

Official device name
Catheter, Conduction, Anesthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5120
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 146 · 2022: 135 · 2023: 79 · 2024: 98 · 2025: 140 · 2026: 134
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
EDEN ControlCath (K241410)Jmt Co., Ltd.2025-02-13
Perifix FX Catheter; Contiplex FX Catheter (K231242)B.Braun Medical, Inc.2023-09-15
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) (K230603)Teleflex Medical2023-08-30
SubQKath Catheter and Needle Set (K193664)Hk Surgical2020-09-09
Percutaneous Introducer (K200624)Epimed International, Inc.2020-04-27
C-CAT Anaesthesia Catheter kit (K191470)Cimpax Aps2019-10-25
Medline Reinforced Epidural Catheter (K181782)Medline Industries, Inc.2019-03-04
EPINAUT (K173541)Imedicom Co., Ltd.2018-08-24
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (K172777)PAJUNK GmbH Medizintechnologie2018-05-03
B. Braun Tear-Away Introducer Needle (K171584)B.Braun Medical, Inc.2017-12-22
Certa Catheter (K171193)Ferrosan Medical Devices Sp. Z.O.O.2017-12-18
UltraCath Continuous Nerve block Catheter (K162522)Teleflexmedical, Inc.2017-03-17
ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit (K161232)Halyard Health2016-09-30
Perifix and Contiplex Catheter (K153297)B.Braun Medical, Inc.2016-08-12
E-Cath (K152952)PAJUNK GmbH Medizintechnologie2016-07-13
Medline Epidural Catheter (K150731)Medline Industries, Inc.2016-03-07
SPINAUT-E, SPINAUT-I (K150789)Imedicom Co., Ltd.2016-03-01
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET (K140110)Teleflex, Inc.2015-03-27
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set (K143164)Kimberly-Clark Corporation2014-12-02
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) (K133316)Epimed International, Inc.2014-05-28
VITAL 5 RELEAF CATHETER (K122661)Vital 52013-02-27
PAINFUSOR CATHETER (K111031)Plan 1 Health, S.R.L.2011-07-08
AMBIT TUNNELER (K110814)Summit Medical Products, Inc.2011-04-08
IO-FLEX CATHETER (K102594)Baxano, Inc.2011-01-19
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH (K102460)Summit Medical Products, Inc.2011-01-13
BUSSE EPIDURAL CATHETER KIT (K093920)Busse Hospital Disposables2010-08-06
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. (K090884)B.Braun Medical, Inc.2009-06-29
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT (K081404)Spinal Integration, LLC2008-10-21
PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT (K080675)PAJUNK GmbH Medizintechnologie2008-06-20
STRYKER ANTIMIC CATHETER (K072702)Stryker Instruments, Instruments Div.2008-03-19
PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS (K072050)Life-Tech, Inc.2007-10-18
BUSSE EPIDURAL CATHETER (K070465)Busse Hospital Disposables, Inc.2007-07-19
ON-Q INTRODUCERS (K063234)I-Flow Corp.2006-11-21
PORTEX EPIDURAL CATHETER (K062005)Smiths Medical Asd, Inc.2006-10-18
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER (K051401)I-Flow Corp.2005-11-30
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 (K051524)Smiths Medical Asd, Inc.2005-07-07
AMT NANOCATH (K050557)American Medical Technologies, Inc.2005-05-27
MODIFICATION TO SOAKER CATHETER (K043456)I-Flow Corp.2005-01-11
PERIFIX CATHETER AND CONTIPLEX CATHETER (K042488)B.Braun Medical, Inc.2004-09-30
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM (K032390)Ebi, L.P.2003-08-29
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 (K023140)Epimed International, Inc.2003-08-15
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM (K023233)Ebi, L.P.2002-12-13
PERIFIX CATHETER CONNECTOR (K022019)B.Braun Medical, Inc.2002-08-01
TE ME NA EPIDURAL CATHETER (K991259)Te ME NA S.A.R.L.2001-02-21
SPIROL EPIDURAL CATHETER (K000886)Abbott Laboratories2000-10-05
MICOR CONDUCTION CATHETER (K001717)Micor, Inc.2000-09-20
AXIOM MULTIPURPOSE WOUND DRAIN (K993592)Axiom Medical, Inc.2000-05-17
SPRING-WOUND EPIDURAL CATHETER (K991879)Micor, Inc.1999-10-28
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 (K992471)Sims Portex, Inc.1999-10-22
FETH-R-KATH (K981329)Epimed International, Inc.1998-08-26
INTERPLEURAL ANESTHESIA CATHETER (K971851)Axiom Medical, Inc.1998-01-22
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER) (K951927)Csen , Ltd.1997-05-30
RACZ EPIDURAL CATHETER (K954584)Medic Evaluation Devices & Instruments Corp.1996-10-08
CATHETER SECUREMENT DEVICE (K951092)Baxter Healthcare Corp1995-03-24
CONCORD/PORTEX EPIDURAL CATHETERS (K935927)Smiths Industries Medical Systems, Inc.1994-09-09
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY (K930539)Medical Components, Inc.1993-08-27
KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE (K930219)Kendall Healthcare Products Co. Div.Of Tyco Health1993-04-27
4 SURE TM ANESTHESIA EXTENSION SET (K924995)Boston Pacific Medical, Inc.1992-12-30
KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH (K922113)Kendall Healthcare Products Co. Div.Of Tyco Health1992-12-03
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL (K897194)Baxter Healthcare Corp1990-06-18
PHARMASEAL EPIDURAL CATHETER (K896712)Baxter Healthcare Corp1990-06-18
BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER (K901129)Medevice, Inc.1990-03-30
EPI-CATH(TM) EPIDURAL CATHETER (K895204)Abbott Laboratories1989-11-15
BIO-MATE(TM) EPIDURAL CATHETER (K884969)Medevice, Inc.1989-06-23
DURACATH, GISH MODEL NO. DVAC-XXXX (K863792)Gish Biomedical, Inc.1986-12-05
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH (K854601)Concord Laboratories, Inc.1986-01-10
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER (K850009)Vas-Cath of Canada , Ltd.1985-05-13
DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER (K850505)Parke-Davis Co.1985-03-11
DESERET EPIDURAL CATHETER (K850439)Parke-Davis Co.1985-03-05
EPIDURAL CATHETER (K840202)Aries Medical, Inc.1984-02-27
3-DAY RELEASE OF ETHYLENE OXIDE DEVICE (K832352)Parke-Davis Co.1984-01-13
EPINEED EPIDURAL CATHETER (K832232)Terumo Medical Corp.1983-08-08
EPIDURAL CATHETER (K823702)Rsp, Inc.1983-01-07
DNA MEDICAL DURACATH (K822436)Moorehead Hospital Products, Inc.1982-10-22
CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG (K802065)Portex, Inc.1980-09-09

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