Company · US
Pfm Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2025. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
10recalls (1 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 6 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 |
| DWM | Apparatus, Suction, Patient Care | 3 |
| FPA | Set, Administration, Intravascular | 3 |
| GCB | Needle, Catheter | 3 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | 3 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 2 |
| PND | Midline Catheter | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DXE | Catheter, Embolectomy | 1 |
| FCG | Biopsy Needle | 1 |
| FXX | Mask, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2025 | K242763 | JetCan® Pro Safety Huber Needle Pfm Medical, Inc. | FPA |
| Jan 14, 2025 | K241278 | ASEPT® Glide Peritoneal Drainage System Pfm Medical, Inc. | PNG |
| May 2, 2023 | K221779 | ASEPT Peritoneal Drainage System Pfm Medical, Inc. | PNG |
| Oct 6, 2022 | K213666 | NuCath Wedge Pressure Catheter Pfm Medical, Inc. | DQO |
| Aug 19, 2020 | K201137 | Asept Surgical Face Mask Pfm Medical, Inc. | FXX |
| Oct 28, 2019 | K192802 | primeMidline Catheters Pfm Medical, Inc. | PND |
| Mar 7, 2018 | K173114 | primeMidline Catheters Pfm Medical, Inc. | PND |
| Mar 25, 2014 | K140137 | SAFETY BIOPSY NEEDLE SYSTEM Pfm Medical, Inc. | FCG |
| Jul 16, 2013 | K122402 | LPP (LOW PROFILE PORT) Pfm Medical, Inc. | LJT |
| Mar 13, 2012 | K113354 | VETA PERITONEAL DIALYSIS CATHETER Pfm Medical, Inc. | FJS |
| Sep 21, 2011 | K110914 | TRIPLE LUMEN PFM PICC Pfm Medical, Inc. | LJS |
| Feb 26, 2010 | K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM Pfm Medical, Inc. | PNG |
| Nov 6, 2009 | K093307 | ASEPT PLEURAL DRAINAGE SYSTEM Pfm Medical, Inc. | DWM |
| Mar 19, 2009 | K083873 | PICC (CT RATED AND NON-RATED) Pfm Medical, Inc. | LJS |
| Mar 7, 2008 | K072481 | JET PORT PLUS HP CATHETER SYSTEM Pfm Medical, Inc. | LJT |
| Dec 12, 2007 | K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT Pfm Medical, Inc. | LJT |
| Nov 19, 2007 | K072391 | PFM PICC Pfm Medical, Inc. | LJS |
| Oct 17, 2007 | K071993 | T-PORT HP INFUSION PORT Pfm Medical, Inc. | LJT |
| Aug 30, 2007 | K071846 | MODIFICATION TO EZ HUBER SAFETY INFUSION SET Pfm Medical, Inc. | FPA |
| Sep 17, 2004 | K040533 | EZ HUBER SAFETY INFUSION SET Pfm Medical, Inc. | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2026 | PFM MEDICAL INC. Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 Open, Classified |
DXE | K011783 |
| Dec 12, 2014 | Pfm Medical Inc ASEPT 2000 ml Drainage Bag, Ref No. 622280
Product Usage:
The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only. Terminated |
FJS | K093796 K113354 |
| Dec 12, 2014 | Pfm Medical Inc Veta Peritoneal Catheter Kit, Curled, Ref No. M7225
Product Usage:
Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity. Terminated |
GCB | None listed |
| Dec 12, 2014 | Pfm Medical Inc Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004
Product Usage:
Short term percutaneous fluid drainage. Terminated |
GCB | None listed |
| Dec 12, 2014 | Pfm Medical Inc ASEPT Peritoneal Drainage System, Ref No. P09080002
Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdome Terminated |
LJS | K083873 |
| Dec 12, 2014 | Pfm Medical Inc 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D
Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and Terminated |
LJS | K083873 |
| Dec 12, 2014 | Pfm Medical Inc Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005
Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC cathete Terminated |
LJS | K083873 |
| Dec 12, 2014 | Pfm Medical Inc ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052
Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from t Terminated |
DWM | K093307 |
| Dec 12, 2014 | Pfm Medical Inc ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001
Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain acc Terminated |
DWM | K093307 |
| Dec 12, 2014 | Pfm Medical Inc Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513
Product Usage: Short term percutaneous fluid drainage Terminated |
GCB | None listed |