Cleared Traditional

K872230 - MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE

K872230 is an FDA 510(k) clearance for MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE, manufactured by Intermedics, Inc.. The device is a Class 1 Hematology device with product code DBT cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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

FDA 510(k) Submission Details - K872230

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

DBT Device Classification - Class 1, General Controls

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.