Cleared Traditional

K840304 - CATEGORY 17-MICROBIOLOGY DEVICES

K840304 is an FDA 510(k) clearance for CATEGORY 17-MICROBIOLOGY DEVICES, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code HTD cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K840304 · Imm Enterprises , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
98d
Days
Class 1
Risk

K840304 is an FDA 510(k) clearance for the CATEGORY 17-MICROBIOLOGY 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 May 1, 1984 after a review of 98 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

FDA 510(k) Submission Details - K840304

510(k) Number K840304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date May 01, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

HTD Device Classification - Class 1, General Controls

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 58
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K840304.
AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420
K852729 · The Huxley Instrument Corp. · Jul 1985
VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR
K851769 · Artiberia · Jun 1985
VARIOUS DRESSING TISSUE FROCEPS(GILLIES, JEANS, RA
K851770 · Artiberia · Jun 1985
CAT. 14-CLINICAL TOXIOLOGY DEVICES
K840318 · Imm Enterprises , Ltd. · Apr 1984
CATEGORY 2 GEN. HOSPITAL & PERSONAL USE
K840306 · Imm Enterprises , Ltd. · Mar 1984
CAT. 3 GASTROENTEROLOGY-UROLOGY DEV
K840307 · Imm Enterprises , Ltd. · Mar 1984