Cleared Traditional

K042454 - STRYKER CASSETTE PUMP

K042454 is an FDA 510(k) clearance for STRYKER CASSETTE PUMP, manufactured by Stryker Endoscopy. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K042454 · Stryker Endoscopy · General Hospital
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Dec 2004
Decision
90d
Days
Class 2
Risk

K042454 is an FDA 510(k) clearance for the STRYKER CASSETTE PUMP. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Endoscopy devices

FDA 510(k) Submission Details - K042454

510(k) Number K042454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2004
Decision Date December 09, 2004
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 57
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K042454.
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
K992126 · Circon Corp. · Aug 1999
SUCTION INSTRUMENTATION
K972074 · Walter Lorenz Surgical, Inc. · Jul 1997
CHASE SUCKER
K971022 · Chase Medical, Inc. · Apr 1997
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · Allegiance Healthcare Corp. · Dec 1996
CURITY THORACENTESIS TRAY
K964519 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1996
STRYKER SUCTION REGULATOR
K963648 · Stryker Endoscopy · Nov 1996