Cleared Traditional

K935098 - BABY BOARD

K935098 is an FDA 510(k) clearance for BABY BOARD, manufactured by Sentry Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code BTX cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K935098 · Sentry Medical Products, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
113d
Days
Class 1
Risk

K935098 is an FDA 510(k) clearance for the BABY BOARD. Classified as Board, Arm (with Cover), Sterile (product code BTX), Class I - General Controls.

Submitted by Sentry Medical Products, Inc. (Irvine, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3910 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentry Medical Products, Inc. devices

FDA 510(k) Submission Details - K935098

510(k) Number K935098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1993
Decision Date February 15, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

BTX Device Classification - Class 1, General Controls

Product Code BTX Board, Arm (with Cover), Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3910
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.