Cleared Traditional

K871559 - CELL LIFTER

K871559 is the FDA 510(k) clearance for CELL LIFTER by Corning Costar Corp.. It is a Class 1 Microbiology device (product code LIB) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K871559 · Corning Costar Corp. · Microbiology device
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May 1987
Decision
23d
Days
Class 1
Risk

K871559 is an FDA 510(k) clearance for the CELL LIFTER. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Corning Costar Corp. (Kennebunk, US). The FDA issued a Cleared decision on May 15, 1987 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology 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 Corning Costar Corp. devices

Submission Details

510(k) Number K871559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1987
Decision Date May 15, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIB Device, General Purpose, Microbiology, Diagnostic

All 15
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K871559.
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