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Portable Aspirator

by Sam Say Assoc.

510(k) K791210

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 NumberK791210 Date24 Jul 1979ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
JCX
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

This device is an apparatus for suction, ward use, portable, AC-powered. It is a portable aspirator designed for general and plastic surgery applications.

It is supplied as a reusable device, powered by AC mains, and was cleared via the FDA 510(k) pathway under K791210 with product code JCX. The device is classified as Class II and is intended for use in ward settings.

Questions

AI-generated answers, 26 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 is the PORTABLE ASPIRATOR used for?

    The PORTABLE ASPIRATOR is an apparatus for suction designed for ward use in general and plastic surgery applications, providing AC-powered suction for clinical procedures requiring fluid removal.

  • Is the PORTABLE ASPIRATOR reusable or single-use?

    The device is supplied as a reusable aspirator, meaning it is intended for multiple uses after appropriate cleaning and reprocessing between patients, as indicated in its FDA 510(k) clearance documentation.

  • How is the PORTABLE ASPIRATOR powered?

    The PORTABLE ASPIRATOR is powered by AC mains, making it suitable for use in ward settings where reliable electrical power is available for continuous operation during surgical suction tasks.

  • What regulatory pathway was used for the PORTABLE ASPIRATOR?

    The device was cleared via the FDA 510(k) pathway under submission number K791210, demonstrating substantial equivalence to a legally marketed predicate device for its intended use in ward-based suction applications.

  • What is the product code and device class for the PORTABLE ASPIRATOR?

    The PORTABLE ASPIRATOR has product code JCX and is classified as a Class II medical device, as specified in its FDA 510(k) clearance under regulation number 878.4780 for apparatus, suction, ward use, portable, AC-powered.