Cleared Traditional

BTP(TM) CENTRALINE(TM) SUIT (K914615) - FDA 510(k) Clearance

Class I General Hospital device.

K914615 · Btp Industries, Inc. · General Hospital
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May 1992
Decision
201d
Days
Class 1
Risk

K914615 is an FDA 510(k) clearance for the BTP(TM) CENTRALINE(TM) SUIT. Classified as Suit, Surgical (product code FXO), Class I - General Controls.

Submitted by Btp Industries, Inc. (S. Hamilton, US). The FDA issued a Cleared decision on May 5, 1992 after a review of 201 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Btp Industries, Inc. devices

Submission Details

510(k) Number K914615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1991
Decision Date May 05, 1992
Days to Decision 201 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 129d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FXO Suit, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.