Cleared Traditional

K942820 - H292

K942820 is an FDA 510(k) clearance for H292, manufactured by Bartels, Inc.. The device is a Class 1 Pathology device with product code KIR cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K942820 · Bartels, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
324d
Days
Class 1
Risk

K942820 is an FDA 510(k) clearance for the H292. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Bartels, Inc. (Issaquah, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2280 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bartels, Inc. devices

FDA 510(k) Submission Details - K942820

510(k) Number K942820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1994
Decision Date May 05, 1995
Days to Decision 324 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 77d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

KIR Device Classification - Class 1, General Controls

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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 - KIR Cells, Animal And Human, Cultured

All 80
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K942820.
FRESHFROZENCELLS
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FRESH FROZEN CELLS
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