510(k) Report

510(k) · Decided

Recalled · Class II · 2023

Aspira Peritoneal Drainage System

K212675510(k) SpecialDecided Dec 14, 2021112-day reviewClass II21 CFR 876.5630Recalls 13

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

Merit Medical Systems, Inc. · PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Cleared on Dec 14, 2021 as substantially equivalent to K110396 (C.R. Bard, Inc., 2011) after a 112-day review. Its family tree reaches back 2 generations to 2008. It has been recalled 13 times.

Decided
Dec 14, 2021
Review
112 days
Class
Class II
Product code
PNG
Recalls
13
Predicates
1

Its longest line of descent runs back 2 generations to K081288 (2008). No later device cites it as a predicate yet.

K081288 · Aspira Peritoneal Drainage System · C.R. Bard, Inc. · 2008K110396 · Aspira Peritoneal Drainage System · C.R. Bard, Inc. · 2011 · recalled2005201020152020
K110396 · Aspira Peritoneal Drainage System · C.R. Bard, Inc. · 2011 · recalledK081288 · Aspira Peritoneal Drainage System · C.R. Bard, Inc. · 20080
  1. Root · 2 generations backK081288 Aspira Peritoneal Drainage SystemC.R. Bard, Inc. · 2008
  2. 1 generation backK110396 Aspira Peritoneal Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
  3. This deviceK212675 Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc. · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K081288Aspira Peritoneal Drainage SystemC.R. Bard, Inc.2008—
−1K110396Aspira Peritoneal Drainage SystemC.R. Bard, Inc.201117
0 (this device)K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.2021—
FIG. 1 — Lineage of K212675, 2008–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 PNG? 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 PNG device

  1. #1 K241946 PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L…score 10.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K110396Aspira Peritoneal Drainage System
Summary page 4
…21 CFR §: 876.5630 Device Review Panel: Gastroenterology/Urology Premarket Notification: K110396 Manufacturer: Merit Medical Systems, Inc. This predicate ha…
C.R. Bard, Inc.201117

Also cleared against K110396: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 22, 2023Class IIZ-1915-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1911-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1913-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1916-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1912-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1920-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1918-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1914-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1909-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1910-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1917-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1908-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.
Apr 22, 2023Class IIZ-1919-2023Process controlThere is a potential that valve assemblies will not open. preventing fluid from draining.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K110396.

How does its category compare?

All PNG devices

PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · PNG

1in 2025

2008: 12010: 12011: 12012: 22016: 32020: 12021: 12023: 22024: 12025: 1
2007high 3 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PNG

244in 2016

2016: 244 days median
2007high 244 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PNG

No recall names PNG since 2007.

Adverse event reports per year · PNG

31in 2025

2017: 32018: 62019: 92020: 152021: 152022: 182023: 212024: 182025: 31
2007high 31 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20101—00
20111—00
20122—00
20130—00
20140—00
20150—00
2016324400
20170—03
20180—06
20190—09
20201—015
20211—015
20220—018
20232—021
20241—018
20251—031
20260—0—

What is it indicated for?

The Aspira Peritoneal Drainage System is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. •Aspira Drainage Catheter: The Aspira Drainage catheter is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieves symptoms such as dyspnea or…

Read the full statement (229 words)

The Aspira Peritoneal Drainage System is intended for long-term access of the peritoneal cavity in order to relieve

symptoms such as dyspnea or other symptoms associated with malignant ascites.

•Aspira Drainage Catheter: The Aspira Drainage catheter is indicated for intermittent drainage of recurrent and

symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieves

symptoms such as dyspnea or other symptoms associated with malignant ascites.

•Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for intermittent

drainage.

•Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for

intermittent drainage.

•Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site.

•Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with Aspira, Asept®, PleurX® and

Rocket® catheters.

•Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain

fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.

•Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve

Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe,or

other appropriate method.

Indications for use as stated in the FDA summary.

Also cleared against K110396

3 other devices cite the same predicate.

  • K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016
  • K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable IntroducerCare Fusion · 2012
  • K113854Pleurx Peritoneal Catheter SystemCare Fusion · 2012

More from Merit Medical Systems, Inc.

185 FDA decisions under this applicant name. See the company

  • K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc. · 2026
  • K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
  • P240023/S005WRAPSODY® Cell-Impermeable EndoprosthesisMerit Medical Systems, Inc. · 2026
  • K254073StatSeal DiscMerit Medical Systems, Inc. · 2026
  • K251802STAR RF Ablation SystemMerit Medical Systems, Inc. · 2026

Recent decisions in PNG

The PNG category page

  • K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025
  • K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit…Bard Peripheral Vascular, Inc. · 2024
  • K230319Passio Pump Drainage SystemBearpac Medical · 2023
  • K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023
  • K201155PleurX Peritoneal Catheter SystemCare Fusion · 2020

https://510kreport.com/device/K212675 · printed Nov 4, 2026

Cite this page

510(k) Report. “K212675: Aspira Peritoneal Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212675

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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