510(k) · Cleared

Recalled · Class II · 2014

Asept Pleural Drainage System

K093307510(k) TraditionalCleared Nov 6, 200915-day reviewClass II21 CFR 870.5050Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pfm Medical, Inc. · DWM Apparatus, Suction, Patient Care

Cleared on Nov 6, 2009 as substantially equivalent to K010642 (Denver Biomedicals, Inc., 2001) and 3 other predicates after a 15-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it. It has been recalled 2 times.

Decided: Nov 6, 2009
Review: 15 days
Class: Class II
Product code: DWM
Recalls: 2
Predicates: 4

Its longest line of descent runs back 1 generation to K010642 (2001). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010642 Pleurx Pleural Catheter and Drainage KitsDenver Biomedicals, Inc. · 2001
This deviceK093307 Asept Pleural Drainage SystemPfm Medical, Inc. · 2009
Descendant · cites it directly · 3 of its ownK093796 Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · Recalled
Descendant · 2 generations on · 1 of its ownK221779 ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023
Descendant · 3 generations on · 0 of its ownK241278 ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK113354 Veta Peritoneal Dialysis CatheterPfm Medical, Inc. · 2012 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K093796Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · cites it directly3descendants
K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023 · 2 generations on1descendant
K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025 · 3 generations on0descendants
K113354Veta Peritoneal Dialysis CatheterPfm Medical, Inc. · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010642	Pleurx Pleural Catheter and Drainage Kits	Denver Biomedicals, Inc.	2001	—
0 (this device)	K093307	Asept Pleural Drainage System	Pfm Medical, Inc.	2009	—
+1	K093796	Asept Peritoneal Drainage System	Pfm Medical, Inc.	2010	1
+2	K221779	ASEPT Peritoneal Drainage System	Pfm Medical, Inc.	2023	—
+3	K241278	ASEPT® Glide Peritoneal Drainage System	Pfm Medical, Inc.	2025	—
+2	K113354	Veta Peritoneal Dialysis Catheter	Pfm Medical, Inc.	2012	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K093307, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DWM device

#1 K212696 Aspira Pleural Drainage Systemscore 5.5 · 3 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K010642	Pleurx Pleural Catheter and Drainage Kits Summary page 1 …ion: DWM Equivalent Devices: Manufacturer: Denver Biomedical (Cardinal Health) Name: Pleurx Pleural Catheter 510(k)#: K010642/K011831/K051084/K052436 Device Description: The Asept Pleural Drainage System is a tunneled, long term catheter used to drain acc…	Denver Biomedicals, Inc.	2001	—
*	K011831	Modification to Pleurx Pleural Catheter and Drainage Kits Summary page 1 …DWM Equivalent Devices: Manufacturer: Denver Biomedical (Cardinal Health) Name: Pleurx Pleural Catheter 510(k)#: K010642/K011831/K051084/K052436 Device Description: The Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated…	Denver Biomedical, Inc.	2001	—
*	K051084	Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line Summary page 1 …quivalent Devices: Manufacturer: Denver Biomedical (Cardinal Health) Name: Pleurx Pleural Catheter 510(k)#: K010642/K011831/K051084/K052436 Device Description: The Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid f…	Denver Biomedicals, Inc.	2005	—
*	K052436	Pleurx Pleural Catheter Kit, Model 50-7000 Summary page 1 …t Devices: Manufacturer: Denver Biomedical (Cardinal Health) Name: Pleurx Pleural Catheter 510(k)#: K010642/K011831/K051084/K052436 Device Description: The Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the…	Denver Biomedical, Inc.	2005	—

Also cleared against K010642: 1 other device →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093796	Asept Peritoneal Drainage System	Pfm Medical, Inc.	2010	3

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 20, 2014	Class II	Z-0561-2015	Process control	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Oct 20, 2014	Class II	Z-0562-2015	Process control	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K093796 (Pfm Medical, Inc., 2010) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K010642.

How does its category compare?

All DWM devices

DWM Apparatus, Suction, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DWM

1in 2023

2007high 2 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWM

Too few DWM 510(k)s in any year since 2007 to give a median.

Recalls per year · DWM

2in 2014

2007high 2 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWM

74in 2025

2007high 143 (2021) · low 2 (2007)2025

MAUDE reports naming product code DWM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	2
2008	0	—	0	2
2009	1	—	0	2
2010	0	—	0	8
2011	1	—	0	23
2012	2	—	0	16
2013	1	—	0	78
2014	0	—	2	94
2015	1	—	0	82
2016	1	—	0	49
2017	1	—	0	62
2018	0	—	0	51
2019	1	—	0	57
2020	1	—	0	68
2021	1	—	0	143
2022	0	—	0	62
2023	1	—	0	108
2024	0	—	0	70
2025	0	—	0	74
2026	0	—	0	—

What is it indicated for?

The Asept Pleural Drainage System is intended for

long-term, intermittent drainage of symptomatic,

recurrent, pleural effusions, including malignant

pleural effusions and other pleural effusions that do

not respond to treatment of the underlying disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093307 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093307: Asept Pleural Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093307

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026