Cleared Traditional

K801515 - ABBY II PATIENT MONITOR OR VITAL SIGNS M (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801515 · Abbott Medical Electronics Co. · Cardiovascular device
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Jul 1980
Decision
8d
Days
Class 2
Risk

K801515 is an FDA 510(k) clearance for the ABBY II PATIENT MONITOR OR VITAL SIGNS M. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Abbott Medical Electronics Co. (Fort Worth, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 8 days - a notably fast clearance cycle.

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: 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 Abbott Medical Electronics Co. devices

Submission Details

510(k) Number K801515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1980
Decision Date July 08, 1980
Days to Decision 8 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 337
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