Cleared Traditional

K791049 - SYNALON ROLLER BOTTLE

K791049 is an FDA 510(k) clearance for SYNALON ROLLER BOTTLE, manufactured by Dynatech Laboratories, Inc.. The device is a Class 1 Pathology device with product code KJC cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K791049 · Dynatech Laboratories, Inc. · Pathology device
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Jun 1979
Decision
22d
Days
Class 1
Risk

K791049 is an FDA 510(k) clearance for the SYNALON ROLLER BOTTLE. Classified as Bottle, Roller, Tissue Culture (product code KJC), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979 after a review of 22 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.

View all Dynatech Laboratories, Inc. devices

FDA 510(k) Submission Details - K791049

510(k) Number K791049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1979
Decision Date June 28, 1979
Days to Decision 22 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
55d faster than avg
Panel avg: 77d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

KJC Device Classification - Class 1, General Controls

Product Code KJC Bottle, Roller, 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.