Pfm Medical, Inc.: FDA filings under this applicant name

FDA lists 20 510(k) clearances under the applicant name “Pfm Medical, Inc.” (first 2004, latest 2025), plus 1 PMA decision, across 11 product codes in 4 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 232 days, against 156 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Pfm Medical, Inc. took a median 232 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.

Top product codes

Plus 1 more product codes.

Review panels

• General Hospital (13)
• Gastroenterology and Urology (5)
• Cardiovascular (2)
• Anesthesiology (1)

Most recent Pfm Medical, Inc. 510(k) clearances

10 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

10 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2026-04-21.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Pfm Medical, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT05209828: Post-market Clinical Follow-up of Pfmmedical Ports (Completed, started 2022-04-13)
• NCT03868514: Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket) (Completed, started 2019-07-04)
• NCT02690220: Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh (Completed, started 2016-02-01)
• NCT02100683: Nit-Occlud PDA Post-Approval Study (Completed, started 2014-08)
• NCT01084889: Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6 (Completed, started 2010-04)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Pfm Medical, Inc. (a text match, not an official crosswalk):

• G0379 — Direct admission of patient for hospital observation care (via DWM)

Frequently asked questions

How many FDA 510(k) clearances are listed under Pfm Medical, Inc.?

FDA lists 20 510(k) clearances under the applicant name “Pfm Medical, Inc.” (first 2004, latest 2025), plus 1 PMA decision, across 11 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Pfm Medical, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Pfm Medical, Inc. is 116 days. Since 2017: 232 days, versus 156 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Pfm Medical, Inc.?

The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 4); FPA (Set, Administration, Intravascular, 3); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 3).

Next steps

• See all 20 Pfm Medical, Inc. clearances with predicates and recalls
• Run predicate analysis for product code LJT, Pfm Medical, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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