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Hemovac Chest Drainage Solution

by Snyder Laboratories, Inc.

510(k) K800861

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800861 Date2 May 1980ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Snyder Hemovac Chest Drainage Solution
510(k) Number
FDA Product Code
KDQ
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hemovac Chest Drainage Solution is a chest drainage device designed to evacuate air, blood, or serous fluid from the pleural space or thoracic cavity. It employs a vacuum-assisted system with a disposable, single-use plastic tube and connector assembly to promote drainage and reduce post-surgical complications such as pneumothorax or hemothorax.

This device is supplied sterile, intended for single-use only, and features a 19 French outer diameter (O.D.) drain with a 4-inch long trocar and connector, paired with a 400 ml capacity evacuator. It is manufactured from polyvinyl chloride (PVC) and must be disposed of after initial use. The solution is authorized under FDA 510(k) clearance (K800861) and falls under the KDQ product code for chest drainage systems.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of fluids can the Snyder Hemovac Chest Drainage Solution remove from the pleural space or thoracic cavity?

    The Snyder Hemovac Chest Drainage Solution is specifically designed to evacuate air, blood, or serous fluid from the pleural space or thoracic cavity. This makes it suitable for post-surgical drainage scenarios where these fluids may accumulate, such as after thoracic or cardiac procedures.

  • Is the Snyder Hemovac Chest Drainage Solution reusable, or is it intended for single-use only?

    The Snyder Hemovac Chest Drainage Solution is explicitly intended for single-use only. The device is supplied sterile and must be disposed of after its initial use to maintain patient safety and sterility standards.

  • What is the capacity of the evacuator component in the Snyder Hemovac Chest Drainage Solution, and what size drain tube does it include?

    The evacuator component of the Snyder Hemovac Chest Drainage Solution has a capacity of 400 ml, and it includes a 19 French outer diameter (O.D.) drain tube paired with a 4-inch long trocar and connector.

  • How is the Snyder Hemovac Chest Drainage Solution supplied, and what materials is it made from?

    The Snyder Hemovac Chest Drainage Solution is supplied sterile and consists of a disposable, single-use plastic tube and connector assembly. The device is manufactured from polyvinyl chloride (PVC), ensuring durability while maintaining compatibility with medical-grade standards.

  • What regulatory pathway was followed for FDA clearance of the Snyder Hemovac Chest Drainage Solution, and what product code does it fall under?

    The Snyder Hemovac Chest Drainage Solution received FDA clearance through a 510(k) submission (K800861) under the Traditional clearance type, with a decision of Substantially Equivalent (SESE). It falls under the KDQ product code, which categorizes it as a chest drainage system.