ASEPT PLEURAL DRAINAGE SYSTEM— 510(k) K093307

Clearance details

Applicant

Pfm Medical, Inc.

Product code

Code DWM

Device class

Class 2

Regulation

21 CFR 870.5050

Advisory panel

Cardiovascular

Date received

2009-10-22

Decision date

2009-11-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oceanside, CA, US

• K212696 — Aspira Pleural Drainage System2023-03-03
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• K201404 — Passio Pump Drainage System2020-11-20
• K190292 — Passio Pump Drainage System2019-07-25
• K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit2017-08-17

• K242763 — JetCan® Pro Safety Huber Needle2025-05-02
• K241278 — ASEPT® Glide Peritoneal Drainage System2025-01-14
• K221779 — ASEPT Peritoneal Drainage System2023-05-02
• K213666 — NuCath Wedge Pressure Catheter2022-10-06
• K201137 — Asept Surgical Face Mask2020-08-19

Death

8

Total

8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0561-2015 — ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.Class II·Terminated·Pfm Medical Inc·20141020
• Z-0562-2015 — ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.Class II·Terminated·Pfm Medical Inc·20141020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093307.