Cleared Traditional

K873466 - EXCEL PULSED IRRIGATION/SUCTION SYSTEM

K873466 is the FDA 510(k) clearance for EXCEL PULSED IRRIGATION/SUCTION SYSTEM by Stryker Corp.. It is a Class 2 General Hospital device (product code FQH) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K873466 · Stryker Corp. · General Hospital

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Nov 1987

Decision

70d

Days

Class 2

Risk

K873466 is an FDA 510(k) clearance for the EXCEL PULSED IRRIGATION/SUCTION SYSTEM. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Corp. devices

Submission Details

510(k) Number	K873466 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 1987
Decision Date	November 06, 1987
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

59d faster than avg

Panel avg: 129d · This submission: 70d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	FQH Lavage, Jet
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 880.5475

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 - FQH Lavage, Jet

All 31

Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K873466.

RMI SURGICCAL SITE VISUALIZATION WAND

K922083 · Research Medical, Inc. · Jan 1993

PHARMASEAL WOUND IRRIGATION DEVICE

K874022 · American Pharmaseal Div. Ahsc · Dec 1987

MICRO-AIRE PULSE LAVAGE

K874504 · Micro-Aire Surgical Instruments, Inc. · Dec 1987

DAVOL SURGICAL SUCTION IRRIGATION INSTR

K830386 · C.R. Bard, Inc. · Mar 1983

MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG

K820661 · Micro-Aire Surgical Instruments, Inc. · Apr 1982

ACKRAD N-DO VAGE TUBE

K813607 · Ackrad Laboratories · Feb 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K873466

Stryker Corp.

Kalamazoo, MI · US

HARMON H WOODWORTH

Regulatory profile

124 submissions 121 cleared

98% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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