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 Epimed International, Inc..

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 Dec 18, 2017
Certa Catheter
K171193
Ferrosan Medical Devices Sp. Z.O.O.
Anesthesiology · 238d
Cleared Mar 17, 2017
UltraCath Continuous Nerve block Catheter
K162522
Teleflexmedical, Inc.
Anesthesiology · 189d
Cleared Sep 30, 2016
ON-Q* EchoSpark Echogenic Catheter
K161232
Halyard Health
Anesthesiology · 151d
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 Mar 01, 2016
SPINAUT-E, SPINAUT-I
K150789
Imedicom Co., Ltd.
Anesthesiology · 342d
Cleared Mar 27, 2015
FLEXTIP PLUS EPIDURAL CATHETER
K140110
Teleflex, Inc.
Anesthesiology · 436d
Cleared Dec 02, 2014
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
K143164
Kimberly Clark Corporation
Anesthesiology · 29d
Cleared May 28, 2014
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.
Anesthesiology · 212d
Cleared Feb 27, 2013
VITAL 5 RELEAF CATHETER
K122661
Vital 5
General & Plastic Surgery · 180d
Cleared Jul 08, 2011
PAINFUSOR CATHETER
K111031
Plan 1 Health, S.R.L.
Anesthesiology · 85d
Cleared Apr 08, 2011
AMBIT TUNNELER
K110814
Summit Medical Products, Inc.
Anesthesiology · 15d
Cleared Jun 29, 2009
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
K090884
B.Braun Medical, Inc.
Anesthesiology · 90d

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 →