Cleared Traditional

K914615 - BTP(TM) CENTRALINE(TM) SUIT

K914615 is an FDA 510(k) clearance for BTP(TM) CENTRALINE(TM) SUIT, manufactured by Btp Industries, Inc.. The device is a Class 1 General Hospital device with product code FXO cleared through the Traditional 510(k) pathway after a 201-day FDA review.

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

FDA 510(k) Submission Details - K914615

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.

FXO Device Classification - Class 1, General Controls

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.