Cleared Traditional

HOSPITAL LAUNDRY SERVICES SURGICAL PACKS (K953083) - FDA 510(k) Clearance

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

K953083 · Hospital Laundry Services · General & Plastic Surgery device
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May 1996
Decision
316d
Days
Class 2
Risk

K953083 is an FDA 510(k) clearance for the HOSPITAL LAUNDRY SERVICES SURGICAL PACKS. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Hospital Laundry Services (Wheeling, US). The FDA issued a Cleared decision on May 14, 1996 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Hospital Laundry Services devices

Submission Details

510(k) Number K953083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date May 14, 1996
Days to Decision 316 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
201d slower than avg
Panel avg: 115d · This submission: 316d
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 8
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K953083.
Medline Cardiovascular Procedure Kit
K212258 · Medline Industries, Inc. · Dec 2021
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
K970286 · Medline Industries, Inc. · Mar 1997
MEDLINE RADIOLOGY-DIAGNOSTIC KITS
K962826 · Medline Industries, Inc. · Sep 1996
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY
K934428 · Sherwood Medical Co. · Dec 1993
STERILE INSTRUMENT TRAYS/BASIN SETS
K924468 · Baxter Healthcare Corp · Jul 1993