Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pfm Medical, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
318 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 | 232 | 0 |
| K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | 2025-01-14 | 253 | 0 |
| K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | 2023-05-02 | 315 | 0 |
| K213666 | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | 2022-10-06 | 318 | 0 |
| K201137 | Asept Surgical Face Mask | Pfm Medical, Inc. | 2020-08-19 | 113 | 0 |
| K192802 | primeMidline Catheters | Pfm Medical, Inc. | 2019-10-28 | 28 | 0 |
| K173114 | primeMidline Catheters | Pfm Medical, Inc. | 2018-03-07 | 159 | 0 |
| K140137 | SAFETY BIOPSY NEEDLE SYSTEM | Pfm Medical, Inc. | 2014-03-25 | 62 | 0 |
| K122402 | LPP (LOW PROFILE PORT) | Pfm Medical, Inc. | 2013-07-16 | 343 | 0 |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Pfm Medical, Inc. | 2012-03-13 | 120 | 1 |
| K110914 | TRIPLE LUMEN PFM PICC | Pfm Medical, Inc. | 2011-09-21 | 173 | 0 |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2010-02-26 | 77 | 1 |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2009-11-06 | 15 | 2 |
| K083873 | PICC (CT RATED AND NON-RATED) | Pfm Medical, Inc. | 2009-03-19 | 80 | 3 |
| K072481 | JET PORT PLUS HP CATHETER SYSTEM | Pfm Medical, Inc. | 2008-03-07 | 185 | 0 |
| K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT | Pfm Medical, Inc. | 2007-12-12 | 28 | 0 |
| K072391 | PFM PICC | Pfm Medical, Inc. | 2007-11-19 | 87 | 0 |
| K071993 | T-PORT HP INFUSION PORT | Pfm Medical, Inc. | 2007-10-17 | 89 | 0 |
| K071846 | MODIFICATION TO EZ HUBER SAFETY INFUSION SET | Pfm Medical, Inc. | 2007-08-30 | 56 | 0 |
| K040533 | EZ HUBER SAFETY INFUSION SET | Pfm Medical, Inc. | 2004-09-17 | 200 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda