Medline Epidural Catheter
FDA 510(k) K150731 · Medline Industries, Inc.
510(k) numberK150731
Submission
- Device name
- Medline Epidural Catheter
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- March 20, 2015
- Decision date
- March 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
Other 510(k)s with product code BSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241410 | EDEN ControlCathBSO · Traditional | Jmt Co., Ltd. | 02/13/2025SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | B.Braun Medical, Inc. | 09/15/2023SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | Teleflex Medical | 08/30/2023SE |
| K193664 | SubQKath Catheter and Needle SetBSO · Traditional | Hk Surgical | 09/09/2020SE |
| K200624 | Percutaneous IntroducerBSO · Traditional | Epimed International, Inc. | 04/27/2020SE |
| K191470 | C-CAT Anaesthesia Catheter kitBSO · Traditional | Cimpax Aps | 10/25/2019SE |
| K181782 | Medline Reinforced Epidural CatheterBSO · Traditional | Medline Industries, Inc. | 03/04/2019SE |
| K173541 | EpinautBSO · Traditional | Imedicom Co., Ltd. | 08/24/2018SE |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional | PAJUNK GmbH Medizintechnologie | 05/03/2018SE |
| K171584 | B. Braun Tear-Away Introducer NeedleBSO · Traditional | B.Braun Medical, Inc. | 12/22/2017SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | 07/29/2026SE |
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | 06/22/2026SE |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant…BZE · Traditional | 03/25/2026SE |
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | 02/25/2026SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | 11/20/2025SE |
| K250345 | Medline Bag DecanterLHI · Traditional | 10/24/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | 07/02/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | 04/11/2025SE |
| K242844 | Medline Level 4 Surgical Gown with Breathable SleevesFYA · Traditional | 02/26/2025SE |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle…GEI · Traditional | 12/19/2024SE |
Questions and answers
When was Medline Epidural Catheter cleared by the FDA?
Medline Epidural Catheter (K150731) received a 510(k) decision of Substantially Equivalent on March 7, 2016, 353 days after the submission was received.
What is the product code of K150731?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.