Cleared Traditional

K914935 - HEART PACK II

K914935 is an FDA 510(k) clearance for HEART PACK II, manufactured by Westmark Hospital Supplies. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K914935 · Westmark Hospital Supplies · General & Plastic Surgery device
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Jan 1992
Decision
88d
Days
Class 2
Risk

K914935 is an FDA 510(k) clearance for the HEART PACK II. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Westmark Hospital Supplies (Grand Rapids, US). The FDA issued a Cleared decision on January 31, 1992 after a review of 88 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 Westmark Hospital Supplies devices

FDA 510(k) Submission Details - K914935

510(k) Number K914935 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received November 04, 1991
Decision Date January 31, 1992
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 35
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K914935.
PREP SHAVE KIT (NON-STERILE)
K925016 · Customed, Inc. · Apr 1993
MEDSURG LAPAROSCOPY TRAY
K914036 · Medsurg Industries, Inc. · Mar 1992
STERILE DISPOSABLE WET SKIN SCRUB TRAY
K914174 · Medical Device Inspection Co., Inc. · Feb 1992
WOUND CLOSURE KIT
K910365 · Megadyne Medical Products, Inc. · Mar 1991
MEGA LACERATION KIT
K910368 · Megadyne Medical Products, Inc. · Mar 1991
CUSTOMED ARTHROSCOPY PACK
K902887 · Customed, Inc. · Sep 1990