Cleared Traditional

K042454 - STRYKER CASSETTE PUMP

K042454 is the FDA 510(k) clearance for STRYKER CASSETTE PUMP by Stryker Endoscopy. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 39
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K042454.
SUCTION INSTRUMENTATION
K972074 · Walter Lorenz Surgical, Inc. · Jul 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
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726 · Stryker Endoscopy · Nov 1995
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
K924337 · Deknatel, Inc. · Jul 1993