Cleared Traditional

K853621 - REPLACEMENT PUMP TUBING

K853621 is an FDA 510(k) clearance for REPLACEMENT PUMP TUBING, manufactured by Shaban Mfg. Co.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K853621

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.

JJE Device Classification - Class 1, General Controls

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 159
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