Cleared Traditional

K781797 - PREP TRAY, PREOPERATIVE SKIN (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K781797 · Pharmaseal Div., Baxter Healthcare Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1978
Decision
16d
Days
Class 1
Risk

K781797 is an FDA 510(k) clearance for the PREP TRAY, PREOPERATIVE SKIN. Classified as Skin Prep Tray (product code OJU), Class I - General Controls.

Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1978 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmaseal Div., Baxter Healthcare Corp. devices

Submission Details

510(k) Number K781797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1978
Decision Date November 08, 1978
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 114d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OJU Skin Prep Tray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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.