Cleared Traditional

K923799 - SMOKE EATER

K923799 is an FDA 510(k) clearance for SMOKE EATER, manufactured by Nordex Medical Corp.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K923799 · Nordex Medical Corp. · General Hospital
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Jan 1993
Decision
184d
Days
Class 2
Risk

K923799 is an FDA 510(k) clearance for the SMOKE EATER. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Nordex Medical Corp. (Grand Rapids, US). The FDA issued a Cleared decision on January 29, 1993 after a review of 184 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Nordex Medical Corp. devices

FDA 510(k) Submission Details - K923799

510(k) Number K923799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1992
Decision Date January 29, 1993
Days to Decision 184 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 129d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYD Device Classification - Class 2, Special Controls

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 - FYD Apparatus, Exhaust, Surgical

All 49
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K923799.
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