Cleared Traditional

ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM (K001775) - FDA 510(k) Clearance

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

K001775 · Zoe Medical, Inc. · Cardiovascular device
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Jan 2001
Decision
214d
Days
Class 2
Risk

K001775 is an FDA 510(k) clearance for the ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Zoe Medical, Inc. (Topsfield, US). The FDA issued a Cleared decision on January 12, 2001 after a review of 214 days - an extended review 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: 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 Zoe Medical, Inc. devices

Submission Details

510(k) Number K001775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date January 12, 2001
Days to Decision 214 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 125d · This submission: 214d
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 73
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K001775.
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