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Data / Medical devices / United States / PFM Medical, Inc

PFM Medical, Inc: FDA-registered device maker in Carlsbad, CA, United States, 15 510(k) clearances and 1 PMA approval

PFM Medical, Inc is registered with the FDA (registration 3013666218) in Carlsbad, CA, United States. It lists 28 device types. The FDA files 15 510(k) clearances and 1 PMA approval under its listings, the newest dated May 2, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch PFM Medical, Inc
FDA registration number
3013666218
Address
1916 Palomar Oaks Way Suite 150, Carlsbad, CA, United States, 92008
Owner or operator
PFM MEDICAL, INC (9052164)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 18, 2002
Registered through
2026
Brand names listed
ASEPT, Asept, Asept Drainage Bag, Asept Peritoneal Drainage System, JET PORT PLUS CATHETER SYSTEM, Jet Port, Jet Port Plus HP Catheter System, Jet-Vac and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Patient CareDWM2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-PoweredJCX2Complaint file establishmentaccessdata.fda.gov
Bath, Incubators/Water, AllJTQ1Complaint file establishmentaccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Repackager or relabeleraccessdata.fda.gov
Catheter Introducer KitOFC2Complaint file establishment, Manufactureraccessdata.fda.gov
Catheter, EmbolectomyDXE2Complaint file establishmentaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS2Complaint file establishment, Manufactureraccessdata.fda.gov
Catheter, Peritoneal, Long-Term IndwellingFJS2Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Biopsy, EndomyocardialDWZ2Repackager or relabeleraccessdata.fda.gov
Fluid Drainage TrayPXU1Complaint file establishment, Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Complaint file establishmentaccessdata.fda.gov
Mesh, SurgicalFTM2Repackager or relabeleraccessdata.fda.gov
Microtome, AccessoriesIDL1Complaint file establishmentaccessdata.fda.gov
Microtome, RotaryIDO1Complaint file establishmentaccessdata.fda.gov
Microtome, SlidingKFL1Complaint file establishmentaccessdata.fda.gov
Midline CatheterPND2Complaint file establishment, Manufactureraccessdata.fda.gov
Minor Surgical Procedures TrayPYB1Complaint file establishment, Manufactureraccessdata.fda.gov
Needle, CatheterGCB1Complaint file establishment, Manufactureraccessdata.fda.gov
Occluder, Patent Ductus, ArteriosusMAE3Complaint file establishmentaccessdata.fda.gov
Peritoneal Dialysis Administration KitPPJ2Complaint file establishment, Manufactureraccessdata.fda.gov
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term IndwellingPNG2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, IntravascularLJT2Complaint file establishment, Specification developeraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Complaint file establishment, Manufactureraccessdata.fda.gov
Vascular Access Port KitPXK2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 2, 2023K221779ASEPT Peritoneal Drainage SystemPNGUnknownPfm Medical, Inc.accessdata.fda.gov
March 7, 2018K173114primeMidline CathetersPNDSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
July 16, 2013K122402LPP (LOW PROFILE PORT)LJTSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
March 13, 2012K113354VETA PERITONEAL DIALYSIS CATHETERFJSUnknownPfm Medical, Inc.accessdata.fda.gov
September 21, 2011K110914TRIPLE LUMEN PFM PICCLJSSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
February 26, 2010K093796ASEPT PERITONEAL DRAINAGE SYSTEMPNGUnknownPfm Medical, Inc.accessdata.fda.gov
November 6, 2009K093307ASEPT PLEURAL DRAINAGE SYSTEMDWMSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
March 19, 2009K083873PICC (CT RATED AND NON-RATED)LJSSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
March 7, 2008K072481JET PORT PLUS HP CATHETER SYSTEMLJTSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
December 12, 2007K073210MODIFICATION TO: T-PORT HP INFUSION PORTLJTSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
November 19, 2007K072391PFM PICCLJSSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
October 17, 2007K071993T-PORT HP INFUSION PORTLJTSubstantially EquivalentPfm Medical, Inc.accessdata.fda.gov
January 24, 2002K011783MULTI-SNARE SETDXESubstantially EquivalentPfm Produkte Fur Die Medizin AGaccessdata.fda.gov
July 19, 2000K001716REDON SETJCXSubstantially EquivalentPfm Produkte Fur Die Medizin AGaccessdata.fda.gov
April 12, 2000K000125JET PORT PLUS CATHETER SYSTEMLJTSubstantially EquivalentClinical Plastic Products SAaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
August 16, 2013P120009NIT-OCCLUD PDAMAE4October 17, 2024accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 21, 202698942Class IIOngoingMulti-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310A 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.accessdata.fda.gov
October 20, 201469666Class IITerminatedRapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainagePFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.accessdata.fda.gov

Compare with other makers

Updated June 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.