Cleared Traditional

K001775 - ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM

K001775 is an FDA 510(k) clearance for ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM, manufactured by Zoe Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K001775 · Zoe Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K001775

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.

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 173
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K001775.
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · Cobe Cardiovascular, Inc. · Nov 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061 · A&D Engineering, Inc. · Jan 2001
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
K992413 · Medical Data Electronics · Aug 1999
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
K992411 · Medical Data Electronics · Aug 1999
ATLAS MONITOR
K984033 · Welch Allyn, Inc. · Jul 1999