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Prospera Spectruum Negative Pressure Wound Therapy System

by Deroyal Industries, Inc.

510(k) K230233

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 NumberK230233 Date18 Apr 2024ClearedStatusActive

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  • Withdrawn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
OMP
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Prospera Spectruum Negative Pressure Wound Therapy System is a powered suction pump device classified as a Negative Pressure Wound Therapy Powered Suction Pump under device class 2. It is substantially equivalent to predicate devices and has received traditional 510(k) clearance from the FDA.

The system is supplied for use in acute and post-acute settings and is indicated for use on a variety of wound types. It is manufactured by Deroyal Industries, Inc., with FDA 510(k) authorization under K230233 and registration numbers including 1419937 and 1000208624, and is regulated under regulation number 878.4780.

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See all devices from Deroyal Industries, Inc. →

Questions

AI-generated answers, 1 Oct 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 Prospera Spectruum Negative Pressure Wound Therapy System used for?

    The Prospera Spectruum Negative Pressure Wound Therapy System is indicated for use on a variety of wound types in acute and post-acute settings, providing powered suction to support wound healing as a Negative Pressure Wound Therapy Powered Suction Pump.

  • How is the Prospera Spectruum system supplied and powered?

    The system is supplied as a powered suction pump device, requiring electrical power to operate, and is designed for repeated use in clinical environments with appropriate maintenance and accessory components.

  • What regulatory clearance does the Prospera Spectruum system have?

    The Prospera Spectruum Negative Pressure Wound Therapy System has received traditional 510(k) clearance from the FDA under K230233, confirming it is substantially equivalent to predicate devices in its class.