Cleared Traditional

K012991 - NEPTUNE WASTE MANAGEMENT STSTEM

K012991 is the FDA 510(k) clearance for NEPTUNE WASTE MANAGEMENT STSTEM by Stryker Instruments. It is a Class 2 General Hospital device (product code FYD) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K012991 · Stryker Instruments · General Hospital
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Nov 2001
Decision
84d
Days
Class 2
Risk

K012991 is an FDA 510(k) clearance for the NEPTUNE WASTE MANAGEMENT STSTEM. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on November 29, 2001 after a review of 84 days - a notably fast clearance 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: 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 Stryker Instruments devices

Submission Details

510(k) Number K012991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date November 29, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
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