Cleared Traditional

K812158 - LKB-BROMMA 2188 ULTROTOME NOVA (FDA 510(k) Clearance)

Class I Hematology device.

K812158 · Lkb Instruments, Inc. · Hematology device
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Sep 1981
Decision
49d
Days
Class 1
Risk

K812158 is an FDA 510(k) clearance for the LKB-BROMMA 2188 ULTROTOME NOVA. Classified as Microtome, Ultra (product code IDM), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1981 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.3010 - the FDA hematology 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 Lkb Instruments, Inc. devices

Submission Details

510(k) Number K812158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1981
Decision Date September 16, 1981
Days to Decision 49 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 113d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IDM Microtome, Ultra
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
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.