Cleared Traditional

K853621 - REPLACEMENT PUMP TUBING

K853621 is the FDA 510(k) clearance for REPLACEMENT PUMP TUBING by Shaban Mfg. Co.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K853621 · Shaban Mfg. Co. · Chemistry device
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Dec 1985
Decision
98d
Days
Class 1
Risk

K853621 is an FDA 510(k) clearance for the REPLACEMENT PUMP TUBING. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Shaban Mfg. Co. (Fort Myers, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Shaban Mfg. Co. devices

Submission Details

510(k) Number K853621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1985
Decision Date December 05, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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.

Regulatory Peers - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 141
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