Cleared Traditional

PROCEDURE READY TRAYS (K884577) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884577 · Professional Medical Services · General Hospital
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Aug 1989
Decision
273d
Days
Class 2
Risk

K884577 is an FDA 510(k) clearance for the PROCEDURE READY TRAYS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Professional Medical Services (North Salt Lake, US). The FDA issued a Cleared decision on August 1, 1989 after a review of 273 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Professional Medical Services devices

Submission Details

510(k) Number K884577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received November 01, 1988
Decision Date August 01, 1989
Days to Decision 273 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
144d slower than avg
Panel avg: 129d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 128
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K884577.
SPLIT-SECOND INTRODUCER
K902527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · Abbott Laboratories · Aug 1990
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989
TERUMO SURFLO(R) I.V. CATHETER
K891087 · Terumo Medical Corp. · Jun 1989
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
K884325 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · Baxter Healthcare Corp · Jun 1988