Pleural Drainage Reservoir

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K820765 ↗

FDA Product Code

GCX

Device Class

Class II

Regulation

21 CFR Part 880.6740

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Heslin Dispos. Tubing Set

  Class II

  FDA 510(k) K843041 Active Cleared 21 Nov 1984

• Phacoemulsification Kits

  Class II

  FDA 510(k) K840695 Active Cleared 22 May 1984

• Acuvac(Tm) Suction Reservoir 400cc and

  Class I

  FDA 510(k) K801350 Active Cleared 14 Jul 1980

• Irrigation, Aspiration Tubing Sets

  Class II

  FDA 510(k) K841072 Active Cleared 29 Mar 1984

• Disposable Scleral Globe Plug LXP

  Class II

  FDA 510(k) K840693 Active Cleared 22 May 1984

• Ispvac Tm

  Class I

  FDA 510(k) K802973 Active Cleared 19 Dec 1980

See all devices from Innovative Surgical Products, Inc. →

• What is the Pleural Drainage Reservoir primarily used for in clinical settings?

  The Pleural Drainage Reservoir is designed to collect and manage fluid from the pleural space, helping treat pleural effusion—a condition where excess fluid builds up around the lungs. This aids in relieving symptoms like shortness of breath (dyspnea) and improving breathing by evacuating the fluid, making it essential for respiratory function support in hospital environments.

• Is the Pleural Drainage Reservoir intended for reuse, or is it meant to be used only once?

  The device is explicitly labeled as a single-use component within a pleural drainage system. It is not designed for reuse, which aligns with standard medical device practices for maintaining sterility and patient safety during pleural fluid management.

• How is the device regulated, and what does its FDA clearance status mean for buyers?

  The Pleural Drainage Reservoir holds an FDA 510(k) clearance (K820765) with a decision labeled *Substantially Equivalent*, meaning it has been determined to be as safe and effective as a legally marketed device that predates the modern regulatory framework. This clearance confirms its compliance with U.S. regulatory standards for pleural drainage systems in general hospital settings.

• Are there any special storage instructions provided for this device beyond standard medical device handling?

  The provided documentation does not specify unique sterility or storage conditions beyond what is typical for medical devices. Buyers should follow standard protocols for sterile medical supplies, ensuring the device remains uncontaminated until use in a pleural drainage system.