Medical Device Manufacturer · US , Oceanside , CA

Pfm Medical, Inc. - FDA 510(k) Cleared Devices

20 submissions · 17 cleared · Since 2004

Recent clearances: JetCan® Pro Safety Huber Needle, ASEPT® Glide Peritoneal Drainage System, ASEPT Peritoneal Drainage System

20
Total
17
Cleared
0
Denied

Pfm Medical, Inc. has 17 FDA 510(k) cleared medical devices. Based in Oceanside, US.

Latest FDA clearance: May 2025. Active since 2004. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by Pfm Medical, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Pfm Medical, Inc.

20 devices
1-20 of 20
Cleared May 02, 2025
JetCan® Pro Safety Huber Needle
K242763 · FPA
General Hospital · 232d
Cleared Jan 14, 2025
ASEPT® Glide Peritoneal Drainage System
K241278 · PNG
Gastroenterology & Urology · 253d
Cleared May 02, 2023
ASEPT Peritoneal Drainage System
K221779 · PNG
Gastroenterology & Urology · 315d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666 · DQO
Cardiovascular · 318d
Cleared Aug 19, 2020
Asept Surgical Face Mask
K201137 · FXX
General Hospital · 113d
Cleared Oct 28, 2019
primeMidline Catheters
K192802 · PND
General Hospital · 28d
Cleared Mar 07, 2018
primeMidline Catheters
K173114 · PND
General Hospital · 159d
Cleared Mar 25, 2014
SAFETY BIOPSY NEEDLE SYSTEM
K140137 · FCG
Gastroenterology & Urology · 62d
Cleared Jul 16, 2013
LPP (LOW PROFILE PORT)
K122402 · LJT
General Hospital · 343d
Cleared Mar 13, 2012
VETA PERITONEAL DIALYSIS CATHETER
K113354 · FJS
Gastroenterology & Urology · 120d
Cleared Sep 21, 2011
TRIPLE LUMEN PFM PICC
K110914 · LJS
General Hospital · 173d
Cleared Feb 26, 2010
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796 · PNG
Gastroenterology & Urology · 77d
Cleared Nov 06, 2009
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · DWM
Anesthesiology · 15d
Cleared Mar 19, 2009
PICC (CT RATED AND NON-RATED)
K083873 · LJS
General Hospital · 80d
Cleared Mar 07, 2008
JET PORT PLUS HP CATHETER SYSTEM
K072481 · LJT
General Hospital · 185d
Cleared Dec 12, 2007
MODIFICATION TO: T-PORT HP INFUSION PORT
K073210 · LJT
General Hospital · 28d
Cleared Nov 19, 2007
PFM PICC
K072391 · LJS
General Hospital · 87d
Cleared Oct 17, 2007
T-PORT HP INFUSION PORT
K071993 · LJT
General Hospital · 89d
Cleared Aug 30, 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K071846 · FPA
General Hospital · 56d
Cleared Sep 17, 2004
EZ HUBER SAFETY INFUSION SET
K040533 · FPA
General Hospital · 200d
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