Cleared Traditional

K860790 - BIOMECCA CARETAKER 1000 & 2000

K860790 is an FDA 510(k) clearance for BIOMECCA CARETAKER 1000 & 2000, manufactured by Biomecca Australia , Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K860790 · Biomecca Australia , Ltd. · Cardiovascular device
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May 1986
Decision
65d
Days
Class 2
Risk

K860790 is an FDA 510(k) clearance for the BIOMECCA CARETAKER 1000 & 2000. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Biomecca Australia , Ltd. (Marrickville, Sydney, AU). The FDA issued a Cleared decision on May 8, 1986 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: 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 Biomecca Australia , Ltd. devices

FDA 510(k) Submission Details - K860790

510(k) Number K860790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date May 08, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 455
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K860790.
MODEL 43200A CARDIAC MONITOR
K861992 · Hewlett-Packard Co. · Jun 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · Hewlett-Packard Co. · May 1986
FASTRACE III, ECG ELECTRODE
K860636 · Andover Medical, Inc. · May 1986
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
K854840 · Ivy Biomedical Systems, Inc. · May 1986
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
CARDIMAX FX-1164
K853979 · Brentwood Instruments, Inc. · Feb 1986