PFM Medical GmbH
Carlsbad, CA, US
PFM Medical GmbH appears in FDA device records in Carlsbad, CA. FDA records list 20 510(k) clearances between and , 5 PMA records and 2 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for PFM Medical GmbH between 2004 and 2025. The busiest year on record is 2007, with 4. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2007 | 4 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242763 | JetCan® Pro Safety Huber Needle | FPA | Substantially Equivalent | |
| K241278 | ASEPT® Glide Peritoneal Drainage System | PNG | Substantially Equivalent | |
| K221779 | ASEPT Peritoneal Drainage System | PNG | Unknown | |
| K213666 | NuCath Wedge Pressure Catheter | DQO | Substantially Equivalent | |
| K201137 | Asept Surgical Face Mask | FXX | Substantially Equivalent | |
| K192802 | primeMidline Catheters | PND | Substantially Equivalent | |
| K173114 | primeMidline Catheters | PND | Substantially Equivalent | |
| K140137 | SAFETY BIOPSY NEEDLE SYSTEM | FCG | Substantially Equivalent | |
| K122402 | LPP (LOW PROFILE PORT) | LJT | Substantially Equivalent | |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | FJS | Unknown | |
| K110914 | TRIPLE LUMEN PFM PICC | LJS | Substantially Equivalent | |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | PNG | Unknown | |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | DWM | Substantially Equivalent | |
| K083873 | PICC (CT RATED AND NON-RATED) | LJS | Substantially Equivalent | |
| K072481 | JET PORT PLUS HP CATHETER SYSTEM | LJT | Substantially Equivalent | |
| K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT | LJT | Substantially Equivalent | |
| K072391 | PFM PICC | LJS | Substantially Equivalent | |
| K071993 | T-PORT HP INFUSION PORT | LJT | Substantially Equivalent | |
| K071846 | MODIFICATION TO EZ HUBER SAFETY INFUSION SET | FPA | Substantially Equivalent | |
| K040533 | EZ HUBER SAFETY INFUSION SET | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617465 | 3003769549 | PFM Medical GmbH | WANKLESTRASSE 60, COLOGNE North Rhine-Westphalia 50996 DE | 2026 | |
| 3013666218 | 3013666218 | PFM Medical, Inc | 1916 Palomar Oaks Way, Carlsbad, CA 92008 US | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- DWMApparatus, Suction, Patient Care
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- JTQBath, Incubators/Water, All
- FCGBiopsy Needle
- KDQBottle, Collection, Vacuum
- EOQBronchoscope (Flexible Or Rigid)
- OFCCatheter Introducer Kit
- DXECatheter, Embolectomy
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FJSCatheter, Peritoneal, Long-Term Indwelling
- FMHContainer, Specimen, Sterile
- DWZDevice, Biopsy, Endomyocardial
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PXUFluid Drainage Tray
- HTDForceps
- DYBIntroducer, Catheter
- KDDKit, Surgical Instrument, Disposable
- FXXMask, Surgical
- FTMMesh, Surgical
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
- FTLMesh, Surgical, Polymeric
- IDLMicrotome, Accessories
- IDOMicrotome, Rotary
- KFLMicrotome, Sliding
- PNDMidline Catheter
- PYBMinor Surgical Procedures Tray
- GCBNeedle, Catheter
- MAEOccluder, Patent Ductus, Arteriosus
- PPJPeritoneal Dialysis Administration Kit
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FPASet, Administration, Intravascular
- GAHStylet, Surgical, General & Plastic Surgery
- IEGTable, Slide Warming
- PXKVascular Access Port Kit
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2526-2026 | Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation. | Class II | Open, Classified | |
| Z-0568-2015 | 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. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0567-2015 | 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. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0566-2015 | Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0565-2015 | 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 abdomen. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0564-2015 | 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 power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0563-2015 | 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 catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0562-2015 | 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 the chest or abdomen. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0561-2015 | 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 accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated | |
| Z-0560-2015 | Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain