# Pfm Medical, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 21 (2004–2025): 20 510(k) clearances and 1 original PMA approval
- Product codes: LJT (4), PNG (3), FPA (3), LJS (3), PND (2), MAE (1), DWM (1), DQO (1), FXX (1), FCG (1), FJS (1)
- 510(k) review time since 2016: median 232 days, against 181 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 32 (11 its own); citations of its devices by later devices: 19 (11 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Denver Biomedical, Inc.: 4 (https://510kreport.com/company/denver-biomedical)
- Medcomp: 3 (https://510kreport.com/company/medcomp)
- Denver Biomedicals, Inc.: 2 (https://510kreport.com/company/denver-biomedicals)
- Hdc Corp.: 2 (https://510kreport.com/company/hdc)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Clinical Plastic Products SA: 2 (https://510kreport.com/company/clinical-plastic-products)
- Pfm Produkte Fur Die Medizin AG: 1 (https://510kreport.com/company/pfm-produkte-fur-die-medizin)
- NuMED, Inc.: 1 (https://510kreport.com/company/numed)

## Firms that cite its devices most
- Navilyst Medical, Inc.: 3 (https://510kreport.com/company/navilyst-medical)
- Dong Guan Kinyet Metal Products Co., Ltd.: 1 (https://510kreport.com/company/dong-guan-kinyet-metal-products)
- Medcomp: 1 (https://510kreport.com/company/medcomp)
- Health Line International Corporation: 1 (https://510kreport.com/company/health-line-international)
- Guangdong Haiou Medical Apparatus Co., Ltd.: 1 (https://510kreport.com/company/guangdong-haiou-medical-apparatus)
- Corbin Clinical Resources, LLC: 1 (https://510kreport.com/company/corbin-clinical-resources)

## Its most-cited devices
- K201137: Asept Surgical Face Mask (2020), cited by 2
- K093796: Asept Peritoneal Drainage System (2010), cited by 2
- K071846: Modification to EZ Huber Safety Infusion Set (2007), cited by 2
- K083873: Picc (CT Rated and Non-Rated) (2009), cited by 2
- K071993: T-Port HP Infusion Port (2007), cited by 2
- K072481: Jet Port Plus HP Catheter System (2008), cited by 2

## Recent decisions
- K242763: JetCan® Pro Safety Huber Needle (May 2, 2025)
- K241278: ASEPT® Glide Peritoneal Drainage System (Jan 14, 2025)
- K221779: ASEPT Peritoneal Drainage System (May 2, 2023)
- K213666: NuCath Wedge Pressure Catheter (Oct 6, 2022)
- K201137: Asept Surgical Face Mask (Aug 19, 2020)
- K192802: primeMidline Catheters (Oct 28, 2019)
- K173114: primeMidline Catheters (Mar 7, 2018)
- K140137: Safety Biopsy Needle System (Mar 25, 2014)

Source page: https://510kreport.com/company/pfm-medical