BSO · Class II · 21 CFR 868.5120

FDA Product Code BSO: Catheter, Conduction, Anesthetic

Leading manufacturers include B.Braun Medical, Inc., Parke-Davis Co. and Baxter Healthcare Corp.

75
Total
75
Cleared
162d
Avg days
1980
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 272d recently vs 161d historically

FDA 510(k) Cleared Catheter, Conduction, Anesthetic Devices (Product Code BSO)

75 devices
1–24 of 75
Cleared Feb 13, 2025
EDEN ControlCath
K241410
Jmt Co., Ltd.
Anesthesiology · 272d
Cleared Sep 15, 2023
Perifix FX Catheter
K231242
B.Braun Medical, Inc.
Anesthesiology · 137d
Cleared Aug 30, 2023
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C)
K230603
Teleflex Medical
Anesthesiology · 180d
Cleared Sep 09, 2020
SubQKath Catheter and Needle Set
K193664
Hk Surgical
Anesthesiology · 253d
Cleared Apr 27, 2020
Percutaneous Introducer
K200624
Epimed International, Inc.
Anesthesiology · 48d
Cleared Oct 25, 2019
C-CAT Anaesthesia Catheter kit
K191470
Cimpax Aps
Anesthesiology · 144d
Cleared Mar 04, 2019
Medline Reinforced Epidural Catheter
K181782
Medline Industries, Inc.
Anesthesiology · 244d
Cleared Aug 24, 2018
EPINAUT
K173541
Imedicom Co., Ltd.
Anesthesiology · 282d
Cleared May 03, 2018
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
K172777
PAJUNK GmbH Medizintechnologie
Anesthesiology · 231d
Cleared Dec 22, 2017
B. Braun Tear-Away Introducer Needle
K171584
B.Braun Medical, Inc.
Anesthesiology · 205d
Cleared Mar 17, 2017
UltraCath Continuous Nerve block Catheter
K162522
Teleflexmedical, Inc.
Anesthesiology · 189d
Cleared Aug 12, 2016
Perifix and Contiplex Catheter
K153297
B.Braun Medical, Inc.
Anesthesiology · 273d
Cleared Jul 13, 2016
E-Cath
K152952
PAJUNK GmbH Medizintechnologie
Anesthesiology · 281d
Cleared Mar 07, 2016
Medline Epidural Catheter
K150731
Medline Industries, Inc.
Anesthesiology · 353d
Cleared Jun 29, 2009
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
K090884
B.Braun Medical, Inc.
Anesthesiology · 90d
Cleared Jun 20, 2008
PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
K080675
PAJUNK GmbH Medizintechnologie
Anesthesiology · 102d
Cleared Nov 21, 2006
ON-Q INTRODUCERS
K063234
I-Flow Corp.
Anesthesiology · 27d
Cleared Oct 18, 2006
PORTEX EPIDURAL CATHETER
K062005
Smiths Medical Asd, Inc.
Anesthesiology · 93d
Cleared Nov 30, 2005
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
K051401
I-Flow Corp.
Anesthesiology · 183d
Cleared Jul 07, 2005
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
K051524
Smiths Medical Asd, Inc.
Anesthesiology · 29d
Cleared Jan 11, 2005
MODIFICATION TO SOAKER CATHETER
K043456
I-Flow Corp.
Anesthesiology · 27d
Cleared Sep 30, 2004
PERIFIX CATHETER AND CONTIPLEX CATHETER
K042488
B.Braun Medical, Inc.
Anesthesiology · 17d
Cleared Aug 29, 2003
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K032390
Ebi, L.P.
Anesthesiology · 25d
Cleared Dec 13, 2002
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233
Ebi, L.P.
Anesthesiology · 77d

About Product Code BSO - Regulatory Context

510(k) Submission Activity

75 total 510(k) submissions under product code BSO since 1980, with 75 receiving FDA clearance (average review time: 162 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - BSO Product Code

Recent submissions under BSO have taken an average of 272 days to reach a decision - up from 161 days historically. Manufacturers should account for longer review timelines in current project planning.

BSO devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →