Cleared Traditional

K153407 - Stryker Neptune 3 Waste Management System

K153407 is the FDA 510(k) clearance for Stryker Neptune 3 Waste Management System by Stryker Corporation. It is a Class 2 General Hospital device (product code JCX) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K153407 · Stryker Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
152d
Days
Class 2
Risk

K153407 is an FDA 510(k) clearance for the Stryker Neptune 3 Waste Management System. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on April 25, 2016 after a review of 152 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4780 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corporation devices

Submission Details

510(k) Number K153407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date April 25, 2016
Days to Decision 152 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 129d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 14
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K153407.
ZOOM Aspiration Pump
K190105 · Taiwan Biomaterial Co., Ltd. · Feb 2019
TWBM Pump
K180115 · Taiwan Biomaterial Co., Ltd. · Jul 2018
DV-300 Aspirator
K181398 · Ding Hwa Co., Ltd. · Jul 2018
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
K132671 · Stryker Corporation · Dec 2013
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
K122756 · Penumbra, Inc. · Oct 2012
STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU
K914694 · Depuy, Inc. · Jan 1992