Cleared Traditional

K854737 - SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG

K854737 is an FDA 510(k) clearance for SURGICAL IRRIGATION DEVICE (SID)/ARTHRO..., manufactured by Orthopaedic Devices , Ltd.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K854737 · Orthopaedic Devices , Ltd. · General Hospital
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May 1986
Decision
174d
Days
Class 2
Risk

K854737 is an FDA 510(k) clearance for the SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Orthopaedic Devices , Ltd. (Woods Cross, US). The FDA issued a Cleared decision on May 19, 1986 after a review of 174 days - an extended review 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: 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 Orthopaedic Devices , Ltd. devices

FDA 510(k) Submission Details - K854737

510(k) Number K854737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1985
Decision Date May 19, 1986
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K854737.
PHARMASEAL WOUND IRRIGATION DEVICE
K874022 · American Pharmaseal Div. Ahsc · Dec 1987
MICRO-AIRE PULSE LAVAGE
K874504 · Micro-Aire Surgical Instruments, Inc. · Dec 1987
EXCEL PULSED IRRIGATION/SUCTION SYSTEM
K873466 · Stryker Corp. · Nov 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