Cleared Traditional

K902726 - BARTELS EXTRACELLULAR MATRIX

K902726 is an FDA 510(k) clearance for BARTELS EXTRACELLULAR MATRIX, manufactured by Baxter Healthcare Corp. The device is a Class 1 Pathology device with product code KIR cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K902726 · Baxter Healthcare Corp · Pathology device
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Sep 1990
Decision
95d
Days
Class 1
Risk

K902726 is an FDA 510(k) clearance for the BARTELS EXTRACELLULAR MATRIX. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on September 24, 1990 after a review of 95 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K902726

510(k) Number K902726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date September 24, 1990
Days to Decision 95 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
18d slower than avg
Panel avg: 77d · This submission: 95d
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 154
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K902726.
CYTOQUANT A-549 CELLS, CATALOG #03-201
K924623 · Proteins Intl., Inc. · Dec 1992
CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201
K924624 · Proteins Intl., Inc. · Dec 1992
CYTOQUANT HLNFS CELLS, CATLOG #03-151
K924625 · Proteins Intl., Inc. · Dec 1992
MADIN-DARBY CANINE KIDNEY CULTURE CELLS
K896846 · Baxter Healthcare Corp · Feb 1990
BUFFALO GREEN MONKEY KIDNEY CELLS
K871613 · Viromed Laboratories, Inc. · May 1987
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776 · Bartels Immunodiagnostic Supplies, Inc. · Dec 1986