Cleared Traditional

K935985 - DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION

K935985 is an FDA 510(k) clearance for DEROYAL CRITICAL CARE DISPOSABLE WASTE ..., manufactured by Deroyal Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K935985 · Deroyal Industries, Inc. · Cardiovascular device
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Dec 1994
Decision
372d
Days
Class 2
Risk

K935985 is an FDA 510(k) clearance for the DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K935985

510(k) Number K935985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1993
Decision Date December 21, 1994
Days to Decision 372 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 125d · This submission: 372d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 409
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K935985.
TRANSIT-2 INFUSION CATHETER
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CONTROL
K944284 · Daig Corp. · Mar 1995
HIGH PRESSURE TUBING
K941978 · Abbott Laboratories · Dec 1994
SCIMED CHOICE(TM) PTCA GUIDE WIRE
K943192 · Scimed Life Systems, Inc. · Nov 1994
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K943739 · Mallinckrodt Medical · Nov 1994