Cleared Traditional

PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970286 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
45d
Days
Class 2
Risk

K970286 is an FDA 510(k) clearance for the PRESBYTERIAN LINEN SERVICES SURGICAL PACKS. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K970286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1997
Decision Date March 10, 1997
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 109
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K970286.
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K930700 · Medline Industries, Inc. · Jul 1993