Cleared Traditional

K903096 - RACK-IT (R)

K903096 is an FDA 510(k) clearance for RACK-IT, manufactured by Vengo Industries, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K903096 · Vengo Industries, Inc. · General Hospital
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Oct 1990
Decision
80d
Days
Class 2
Risk

K903096 is an FDA 510(k) clearance for the RACK-IT (R). Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Vengo Industries, Inc. (South Lyon, US). The FDA issued a Cleared decision on October 1, 1990 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital 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 Vengo Industries, Inc. devices

FDA 510(k) Submission Details - K903096

510(k) Number K903096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1990
Decision Date October 01, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 Hospital devices follow this clearance model.

Regulatory Peers - FLE Sterilizer, Steam

All 137
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K903096.
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