Cleared Traditional

K895427 - MEDISEAL SUCTION CANISTER

K895427 is an FDA 510(k) clearance for MEDISEAL SUCTION CANISTER, manufactured by Deroyal Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DWD cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K895427 · Deroyal Industries, Inc. · Cardiovascular device
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Jan 1990
Decision
136d
Days
Class 2
Risk

K895427 is an FDA 510(k) clearance for the MEDISEAL SUCTION CANISTER. Classified as Suction Control, Intracardiac, Cardiopulmonary Bypass (product code DWD), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4430 - 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. Standard predicate reliance. 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 - K895427

510(k) Number K895427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date January 19, 1990
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWD Device Classification - Class 2, Special Controls

Product Code DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4430
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 - DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

All 12
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K895427.
B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.
K915480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
K915481 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
MODIFIED RLV-2100 B
K864503 · American Omni Medical, Inc. · Jan 1987
SARNS SAFETY LOOP
K863593 · 3M Health Care, Sarns · Nov 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · Gish Biomedical, Inc. · Aug 1986