Cleared Traditional

K840306 - CATEGORY 2 GEN. HOSPITAL & PERSONAL USE

K840306 is the FDA 510(k) clearance for CATEGORY 2 GEN. HOSPITAL & PERSONAL USE 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 48-day FDA review.

K840306 · Imm Enterprises , Ltd. · General & Plastic Surgery device
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Mar 1984
Decision
48d
Days
Class 1
Risk

K840306 is an FDA 510(k) clearance for the CATEGORY 2 GEN. HOSPITAL & PERSONAL USE. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 48 days - a notably fast clearance cycle.

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: 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 Imm Enterprises , Ltd. devices

Submission Details

510(k) Number K840306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date March 12, 1984
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
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 K840306.
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