Cleared Traditional

K862555 - HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)

K862555 is an FDA 510(k) clearance for HUMAN EPITHELOID CERVIX CARCINOMA CELLS..., manufactured by Viromed Laboratories, Inc.. The device is a Class 1 Pathology device with product code KIR cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K862555 · Viromed Laboratories, Inc. · Pathology device
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Jul 1986
Decision
7d
Days
Class 1
Risk

K862555 is an FDA 510(k) clearance for the HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA). Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Viromed Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 10, 1986 after a review of 7 days - a notably fast clearance cycle.

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: 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 Viromed Laboratories, Inc. devices

FDA 510(k) Submission Details - K862555

510(k) Number K862555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date July 10, 1986
Days to Decision 7 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
70d faster than avg
Panel avg: 77d · This submission: 7d
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 K862555.
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
ULTRACLONE 01-2300 CELL LINE
K861585 · Earl-Clay Laboratories, Inc. · May 1986
ULTRACLONE 01-700 CELL LINE
K861569 · Earl-Clay Laboratories, Inc. · May 1986
HUMAN LUNG CARCINOMA CELLS (A549)
K861373 · Viromed Laboratories, Inc. · Apr 1986