BSO · Class II · 21 CFR 868.5120

FDA Product Code BSO: Catheter, Conduction, Anesthetic

Leading manufacturers include Baxter Healthcare Corp, Abbott Laboratories and Medline Industries, 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 Mar 07, 2016
Medline Epidural Catheter
K150731
Medline Industries, Inc.
Anesthesiology · 353d
Cleared Oct 05, 2000
SPIROL EPIDURAL CATHETER
K000886
Abbott Laboratories
Anesthesiology · 199d
Cleared Mar 24, 1995
CATHETER SECUREMENT DEVICE
K951092
Baxter Healthcare Corp
Anesthesiology · 15d
Cleared Jun 18, 1990
PHARMASEAL EPIDURAL CATHETER
K896712
Baxter Healthcare Corp
Anesthesiology · 202d
Cleared Jun 18, 1990
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
K897194
Baxter Healthcare Corp
Anesthesiology · 171d
Cleared Nov 15, 1989
EPI-CATH(TM) EPIDURAL CATHETER
K895204
Abbott Laboratories
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 →