Cleared Traditional

K770836 - ULTIMAT L4 X L4, LIEBEL-FLARSHEIM

K770836 is an FDA 510(k) clearance for ULTIMAT L4 X L4, manufactured by Mallinckrodt Group, Inc.. The device is a Class 2 Pathology device with product code KPX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K770836 · Mallinckrodt Group, Inc. · Pathology device
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May 1977
Decision
20d
Days
Class 2
Risk

K770836 is an FDA 510(k) clearance for the ULTIMAT L4 X L4, LIEBEL-FLARSHEIM. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1977 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 892.1860 - the FDA pathology 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.

FDA 510(k) Submission Details - K770836

510(k) Number K770836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1977
Decision Date May 26, 1977
Days to Decision 20 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 78d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPX Device Classification - Class 2, Special Controls

Product Code KPX Changer, Radiographic Film/cassette
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1860
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 Pathology devices follow this clearance model.

K770836 · ULTIMAT L4 X L4, LIEBEL-FLARSHEIM
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