Cleared Traditional

K961124 - THE NAUTILUS

K961124 is an FDA 510(k) clearance for THE NAUTILUS, manufactured by Rand Scientific Corp.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K961124 · Rand Scientific Corp. · General & Plastic Surgery device
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Apr 1996
Decision
29d
Days
Class 2
Risk

K961124 is an FDA 510(k) clearance for the THE NAUTILUS. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on April 19, 1996 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - 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 Rand Scientific Corp. devices

FDA 510(k) Submission Details - K961124

510(k) Number K961124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date April 19, 1996
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZE Device Classification - Class 2, Special Controls

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
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 - FZE Prosthesis, Nose, Internal

All 13
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K961124.
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