Cleared Traditional

K872448 - BLOOD CONTAINMENT PACK

K872448 is an FDA 510(k) clearance for BLOOD CONTAINMENT PACK, manufactured by Professional Medical Services. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K872448 · Professional Medical Services · General & Plastic Surgery device
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Nov 1987
Decision
147d
Days
Class 2
Risk

K872448 is an FDA 510(k) clearance for the BLOOD CONTAINMENT PACK. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Professional Medical Services (North Salt Lake, US). The FDA issued a Cleared decision on November 17, 1987 after a review of 147 days - within the typical 510(k) review window.

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. 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 Professional Medical Services devices

FDA 510(k) Submission Details - K872448

510(k) Number K872448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date November 17, 1987
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K872448.
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
K882684 · Standard Textile Co., Inc. · Aug 1988
ALCON SURGICAL PROCEDURE PACKS
K880961 · Alcon Laboratories · Apr 1988
SOFT TISSUE ANCHORING SET KIT
K874439 · Concept, Inc. · Nov 1987
MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S
K871434 · Fraass Survival Systems, Inc. · Jul 1987
SURVIVAL KIT, INDIVIDUAL
K871437 · Fraass Survival Systems, Inc. · Jul 1987
CLOSED CHEST DRAINAGE SET
K871873 · Gish Biomedical, Inc. · Jul 1987