Cleared Traditional

K872230 - MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE (FDA 510(k) Clearance)

Class I Hematology device.

K872230 · Intermedics, Inc. · Hematology device
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Sep 1987
Decision
98d
Days
Class 1
Risk

K872230 is an FDA 510(k) clearance for the MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE. Classified as Factor Xiii A, S, Antigen, Antiserum, Control (product code DBT), Class I - General Controls.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on September 15, 1987 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.5330 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intermedics, Inc. devices

Submission Details

510(k) Number K872230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1987
Decision Date September 15, 1987
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DBT Factor Xiii A, S, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5330
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.