Cleared Special

K212675 - Aspira Peritoneal Drainage System

K212675 is an FDA 510(k) clearance for Aspira Peritoneal Drainage System, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PNG cleared through the Special 510(k) pathway after a 112-day FDA review.

K212675 · Merit Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
112d
Days
Class 2
Risk

K212675 is an FDA 510(k) clearance for the Aspira Peritoneal Drainage System. Classified as Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (product code PNG), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 14, 2021 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K212675

510(k) Number K212675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 24, 2021
Decision Date December 14, 2021
Days to Decision 112 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 131d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

PNG Device Classification - Class 2, Special Controls

Product Code PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
Definition For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling

All 14
Devices cleared under the same product code (PNG) and FDA review panel - the closest regulatory comparables to K212675.
PeritX™ 1L Drainage Kit (90-1010)
K241946 · Bard Peripheral Vascular, Inc. · Dec 2024
Passio Pump Drainage System
K230319 · Bearpac Medical · Nov 2023
ASEPT Peritoneal Drainage System
K221779 · Pfm Medical, Inc. · May 2023
PleurX Peritoneal Catheter System
K201155 · Care Fusion · Oct 2020
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
K162457 · Rocket Medical Plc · Nov 2016
PleurX Peritoneal Catheter System
K160437 · Care Fusion · Nov 2016
K212675 · Aspira Peritoneal Drainage System
Download PDF FDA Summary Merit Medical Systems…