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Plexus/3000 (P/3000), Plexus/3500 (P/3500)

by Plexus Medical

510(k) K952610

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 NumberK952610 Date13 Sep 1995ClearedStatusActive

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  • Withdrawn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
FNM
Device Class
Class II
Regulation
21 CFR Part 880.5550
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Plexus/3000 (P/3000) and Plexus/3500 (P/3500) are air flotation mattresses with alternating pressure, designed for use in general hospital settings. These devices are intended to provide pressure relief and prevent pressure ulcers in patients who are at risk for skin breakdown due to prolonged immobility.

The devices are supplied as non-sterile and are reusable. They are not specifically indicated for MRI safety. The Plexus/3000 and Plexus/3500 have received FDA 510(k) clearance with the product code FNM and regulation number 880.5550, and are classified as Class II medical devices. The devices are manufactured by Plexus Medical and were cleared on September 13, 1995.

Other devices from Plexus Medical

  • Plexus/1000

    Class II

  • P/2000

    Class II

Questions

AI-generated answers, 6 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 are the Plexus/3000 and P/3500 mattresses designed for?

    The Plexus/3000 (P/3000) and Plexus/3500 (P/3500) are air flotation mattresses with alternating pressure, designed for use in general hospital settings to provide pressure relief and prevent pressure ulcers in patients at risk for skin breakdown due to prolonged immobility.

  • How are the Plexus mattresses supplied and are they sterile?

    The devices are supplied as non-sterile and are reusable. They are not specifically indicated for MRI safety. The mattresses are designed for repeated use in hospital environments after appropriate cleaning and disinfection between patients.

  • What is the regulatory status of the Plexus/3000 and P/3500 mattresses?

    The Plexus/3000 and Plexus/3500 have received FDA 510(k) clearance with the product code FNM and regulation number 880.5550, and are classified as Class II medical devices. They were cleared on September 13, 1995.

  • What sizes and models are available for the Plexus mattresses?

    The available models are the Plexus/3000 (P/3000) and Plexus/3500 (P/3500). The device data does not specify different sizes within these models, suggesting these may be standard configurations suitable for general hospital bed applications.