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Neptune Waste Management System

by American Immuno Tech

510(k) K990037

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK990037 Date24 Aug 1999ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0174-05 FDA Unclassified (pre-2012) initiated 12 Oct 2004

    The grounding pin may break inside of the electrical plug, resulting in a shock hazard.

    • Terminated Z-0524-03 FDA Unclassified (pre-2012) initiated 3 Dec 2002

    Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.

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  • Withdrawn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
FYD
Device Class
Class II
Regulation
21 CFR Part 878.5070
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent