Cleared Traditional

K861253 - TISSUE CULTURE FLASK PL 732 PLASTIC

K861253 is an FDA 510(k) clearance for TISSUE CULTURE FLASK PL 732 PLASTIC, manufactured by Travenol Laboratories, S.A.. The device is a Class 1 Pathology device with product code KJA cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K861253 · Travenol Laboratories, S.A. · Pathology device
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Apr 1986
Decision
8d
Days
Class 1
Risk

K861253 is an FDA 510(k) clearance for the TISSUE CULTURE FLASK PL 732 PLASTIC. Classified as Flask, Tissue Culture (product code KJA), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2240 - 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 - K861253

510(k) Number K861253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1986
Decision Date April 11, 1986
Days to Decision 8 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: 78d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

KJA Device Classification - Class 1, General Controls

Product Code KJA Flask, Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2240
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 - KJA Flask, Tissue Culture

All 12
Devices cleared under the same product code (KJA) and FDA review panel - the closest regulatory comparables to K861253.
TISSUE CULTURE BAG
K870865 · American Fluoroseal Corp. · Mar 1987
TISSUE CULTURE FLASK
K864021 · Fenwal Laboratories · Oct 1986
TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD
K862152 · Travenol Laboratories, S.A. · Jun 1986
FETAL BOVINE SERUM IN TRANSFER CONTAINER
K853441 · Newport Biosystems, Inc. · Aug 1985
NEWPORT MEDIA TRANSFER CONTAINER
K852532 · Newport Bio Systems · Aug 1985
CELL SCRAPER
K823138 · Corning Costar Corp. · Nov 1982
K861253 · TISSUE CULTURE FLASK PL 732 PLASTIC
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