Cleared Traditional

K800405 - A-V MINI CLINIC

K800405 is an FDA 510(k) clearance for A-V MINI CLINIC, manufactured by Instromedix, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K800405 · Instromedix, Inc. · Cardiovascular device
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Jul 1980
Decision
146d
Days
Class 2
Risk

K800405 is an FDA 510(k) clearance for the A-V MINI CLINIC. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Instromedix, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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.

FDA 510(k) Submission Details - K800405

510(k) Number K800405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1980
Decision Date July 21, 1980
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 340
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K800405.
HEARTWATCH
K800519 · D. Jenkins · Sep 1980
HS10 PORTABLE OPERATING ROOM MONITOR
K802184 · Medtel Pty. , Ltd. · Sep 1980
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980
ABBY II PATIENT MONITOR OR VITAL SIGNS M
K801515 · Abbott Medical Electronics Co. · Jul 1980
D668 & D664 CENTRAL MONITORING SYSTEMS
K800243 · Medtel Pty. , Ltd. · Apr 1980
PULSEOMETER
K800500 · Kirklands Sporting Goods Co. · Apr 1980
K800405 · A-V MINI CLINIC
Download PDF Instromedix, Inc.