Cleared Traditional

HOLDER, PEDIATRIC POSITION (K922288) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K922288 · Yamashita and Hemsley Business Trust · General & Plastic Surgery device
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Feb 1993
Decision
271d
Days
Class 1
Risk

K922288 is an FDA 510(k) clearance for the HOLDER, PEDIATRIC POSITION. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Yamashita and Hemsley Business Trust (Medford, US). The FDA issued a Cleared decision on February 10, 1993 after a review of 271 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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 Yamashita and Hemsley Business Trust devices

Submission Details

510(k) Number K922288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date February 10, 1993
Days to Decision 271 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
156d slower than avg
Panel avg: 115d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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.