Cleared Traditional

BABY BOARD (K935098) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K935098 · Sentry Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.