Cleared Traditional

K884091 - SOURCERER

K884091 is an FDA 510(k) clearance for SOURCERER, manufactured by John Caunt Scientific , Ltd.. The device is a Class 1 Toxicology device with product code JJJ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K884091 · John Caunt Scientific , Ltd. · Toxicology device
Download Printable Device Report (PDF)
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Feb 1989
Decision
127d
Days
Class 1
Risk

K884091 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 John Caunt Scientific , Ltd. (Eynsham, Oxon, England, GB). The FDA issued a Cleared decision on February 2, 1989 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K884091

510(k) Number K884091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date February 02, 1989
Days to Decision 127 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 87d · This submission: 127d
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 62
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K884091.
GENESYS 6000 GAMMA COUNTER
K900087 · Laboratory Technologies, Inc. · Jul 1990
MATRIX(TM)-96
K896202 · Canberra Industries, Inc. · Jan 1990
SOURCERER
K894902 · Oakfield Instruments, Ltd. · Oct 1989
SAMPLE IDENTIFICATION STATION MODEL 38010
K884269 · Icn Micromedic Systems · Jan 1989
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K874094 · Lkb Instruments, Inc. · Nov 1987
ISO-DATA 100 SERIES GAMMA COUNTER
K872429 · Iso-Data, Inc. · Aug 1987
K884091 · SOURCERER
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