FDA Product Code PND: Midline Catheter
The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.
Leading manufacturers include C.R. Bard, Inc., Pfm Medical, Inc. and Vygon USA.
13
Total
13
Cleared
160d
Avg days
2016
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
140d avg (recent)
FDA 510(k) Cleared Midline Catheter Devices (Product Code PND)
13 devices
Cleared
Dec 18, 2025
Midline Catheter
Terumo Medical Products Hangzhou Co., Ltd.
General Hospital
140d
Cleared
Sep 02, 2022
Arrow Pressure Injectable Midline Catheter
Arrow International, LLC Subsidiary of Teleflex Incorporated
General Hospital
266d
Cleared
May 13, 2022
Provena(TM) Midline Catheter
C.R. Bard, Inc.
General Hospital
226d
Cleared
Aug 27, 2021
Stiletto Extended Dwell Catheter
Piper Access, LLC
General Hospital
231d
Cleared
Oct 28, 2019
primeMidline Catheters
Pfm Medical, Inc.
General Hospital
28d
Cleared
Nov 02, 2018
Vygon Midline 3 Fr SL Catheter
Vygon USA
General Hospital
179d
Cleared
Mar 07, 2018
primeMidline Catheters
Pfm Medical, Inc.
General Hospital
159d
Cleared
Jun 01, 2017
PowerGlide ST Midline Catheter
C.R. Bard, Inc.
General Hospital
134d
Cleared
Dec 14, 2016
PowerMidline Catheter
C.R. Bard, Inc.
General Hospital
58d
Cleared
Jun 28, 2016
PowerMidline Catheter
C.R. Bard, Inc.
General Hospital
217d
About Product Code PND - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code PND since 2016, with 13 receiving FDA clearance (average review time: 160 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - PND Product Code
FDA review times for PND submissions have been consistent, averaging 140 days recently vs 162 days historically.
PND devices are reviewed by the General Hospital panel. Browse all General Hospital devices →