510(k) Report

FDA applicant

Pfm Medical, Inc.

Carlsbad, CA21 decisions2004–20256 recalls

FDA records 21 decisions for Pfm Medical, Inc. (Carlsbad, CA) from 2004 to 2025: 20 510(k) clearances and 1 original PMA approval. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and PNG (Peritoneal, Drainage Catheter For Refractory…). Since 2016 its 510(k)s took a median of 232 days from receipt to decision, against 181 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 11 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Pfm Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 42008: 12009: 22010: 12011: 12012: 12013: 22014: 12018: 12019: 12020: 12022: 12023: 12025: 2
2007high 4 (2007) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

6in 2014

2014: 6
2007high 6 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pfm Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pfm Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular4decisions
  • PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling3decisions
  • FPASet, Administration, Intravascular3decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days3decisions
  • PNDMidline Catheter2decisions
  • MAEOccluder, Patent Ductus, Arteriosus1decision

Also: DWM (1), DQO (1), FXX (1), FCG (1), FJS (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 232 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 181 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 32 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201137Asept Surgical Face MaskPfm Medical, Inc. · 20202cite it
  • K093796Asept Peritoneal Drainage SystemPfm Medical, Inc. · 20102cite it
  • K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 20072cite it
  • K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 20092cite it
  • K071993T-Port HP Infusion PortPfm Medical, Inc. · 20072cite it
  • K072481Jet Port Plus HP Catheter SystemPfm Medical, Inc. · 20082cite it

What has FDA decided for it lately?

  • K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc. · 2025
  • K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025
  • K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023
  • K213666NuCath Wedge Pressure CatheterPfm Medical, Inc. · 2022
  • K201137Asept Surgical Face MaskPfm Medical, Inc. · 2020
  • K192802primeMidline CathetersPfm Medical, Inc. · 2019
  • K173114primeMidline CathetersPfm Medical, Inc. · 2018
  • K140137Safety Biopsy Needle SystemPfm Medical, Inc. · 2014

All 21 as Pfm Medical, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K093307ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001…Oct 20, 2014Class II
  • K083873Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These…Oct 20, 2014Class II
  • K093307ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit…Oct 20, 2014Class II
  • K083873ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT…Oct 20, 2014Class II
  • K0838736F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter…Oct 20, 2014Class II
  • K093796ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to…Oct 20, 2014Class II