Cleared Traditional

K840318 - CAT. 14-CLINICAL TOXIOLOGY DEVICES

K840318 is the FDA 510(k) clearance for CAT. 14-CLINICAL TOXIOLOGY DEVICES by Imm Enterprises , Ltd.. It is a Class 1 General & Plastic Surgery device (product code HTD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K840318 · Imm Enterprises , Ltd. · General & Plastic Surgery device
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Apr 1984
Decision
90d
Days
Class 1
Risk

K840318 is an FDA 510(k) clearance for the CAT. 14-CLINICAL TOXIOLOGY DEVICES. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Imm Enterprises , Ltd. devices

Submission Details

510(k) Number K840318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date April 23, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTD Forceps
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - HTD Forceps

All 8
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K840318.
VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR
K851769 · Artiberia · Jun 1985
VARIOUS DRESSING TISSUE FROCEPS(GILLIES, JEANS, RA
K851770 · Artiberia · Jun 1985
BACKHAUS CLAMP, 5 1/4
K821293 · Conphar, Inc. · May 1982
BACKHAUS CLAMP, 3 1/2
K821298 · Conphar, Inc. · May 1982
ORHTOPEDIC REAMER 87 HTD
K802676 · Zimmer, Inc. · Nov 1980
ACUFEX FORCEPS
K800273 · Acufex Microsurgical, Inc. · Feb 1980