Cleared Traditional

K894006 - SANISERV SURGICAL SLUSH SYSTEM

K894006 is an FDA 510(k) clearance for SANISERV SURGICAL SLUSH SYSTEM, manufactured by Saniserv, Inc.. The device is a Class 1 Physical Medicine device with product code JRM cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K894006 · Saniserv, Inc. · Physical Medicine device
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Nov 1989
Decision
151d
Days
Class 1
Risk

K894006 is an FDA 510(k) clearance for the SANISERV SURGICAL SLUSH SYSTEM. Classified as Freezer (product code JRM), Class I - General Controls.

Submitted by Saniserv, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 3, 1989 after a review of 151 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 862.2050 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Saniserv, Inc. devices

FDA 510(k) Submission Details - K894006

510(k) Number K894006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1989
Decision Date November 03, 1989
Days to Decision 151 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

JRM Device Classification - Class 1, General Controls

Product Code JRM Freezer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.