Cleared Traditional

K880890 - THE S.A.F.E. SYSTEM

K880890 is the FDA 510(k) clearance for THE S.A.F.E. SYSTEM by Pfizer Laser Systems. It is a Class 2 General Hospital device (product code FYD) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K880890 · Pfizer Laser Systems · General Hospital
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May 1988
Decision
70d
Days
Class 2
Risk

K880890 is an FDA 510(k) clearance for the THE S.A.F.E. SYSTEM. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Pfizer Laser Systems (Irvine, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 70 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.

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Submission Details

510(k) Number K880890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date May 11, 1988
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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.