Cleared Traditional

K894902 - SOURCERER

K894902 is an FDA 510(k) clearance for SOURCERER, manufactured by Oakfield Instruments, Ltd.. The device is a Class 1 Toxicology device with product code JJJ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K894902 · Oakfield Instruments, Ltd. · Toxicology device
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Oct 1989
Decision
77d
Days
Class 1
Risk

K894902 is an FDA 510(k) clearance for the SOURCERER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Oakfield Instruments, Ltd. (Oxon Ox8 1ja England, GB). The FDA issued a Cleared decision on October 17, 1989 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2320 - the FDA toxicology 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 Oakfield Instruments, Ltd. devices

FDA 510(k) Submission Details - K894902

510(k) Number K894902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date October 17, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 33
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K894902.
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