Cleared Traditional

K840305 - CATEGORY 1 CIRCULATORY SYSTEM DEVICE

K840305 is an FDA 510(k) clearance for CATEGORY 1 CIRCULATORY SYSTEM DEVICE, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K840305 · Imm Enterprises , Ltd. · Cardiovascular device
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Apr 1984
Decision
90d
Days
Class 1
Risk

K840305 is an FDA 510(k) clearance for the CATEGORY 1 CIRCULATORY SYSTEM DEVICE. Classified as Instruments, Surgical, Cardiovascular (product code DWS), 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 Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Imm Enterprises , Ltd. devices

FDA 510(k) Submission Details - K840305

510(k) Number K840305 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 Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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 - DWS Instruments, Surgical, Cardiovascular

All 52
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K840305.
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140 · Teleflexmedical, Inc. · Jun 1985
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
PMA ANGIOGRAPHY TRAY
K841468 · Professional Medical Services · Jun 1984
LEATHER VALVE CUTTER
K831455 · American V. Mueller · Jul 1983
SCANLAN SINGLE-USE AORTA PUNCH
K823764 · Scanlan Intl., Inc. · Mar 1983
LEATHER VALVULOTOME
K821569 · American V. Mueller · May 1982