Cleared Traditional

K955546 - PATIENT MONITOR MODEL 405P

K955546 is the FDA 510(k) clearance for PATIENT MONITOR MODEL 405P by Ivy Biomedical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K955546 · Ivy Biomedical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
255d
Days
Class 2
Risk

K955546 is an FDA 510(k) clearance for the PATIENT MONITOR MODEL 405P. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on August 16, 1996 after a review of 255 days - an extended review 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: 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 Ivy Biomedical Systems, Inc. devices

Submission Details

510(k) Number K955546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date August 16, 1996
Days to Decision 255 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
130d slower than avg
Panel avg: 125d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 248
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K955546.
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
K963400 · Nellcor Puritan Bennett, Inc. · Nov 1996
AS/3 LIGHT MONITOR
K961247 · Datex Division Instrumentarium Corp. · Oct 1996
HP CATHSTATION - MODEL M1264B
K961401 · Hewlett-Packard Co. · Oct 1996
DINAMAP SELECT MULTI-PARAMETER SYSTEM
K955113 · Johnson & Johnson Medical, Inc. · Aug 1996
CARDIMAX MODEL FX-2111
K955416 · Fukuda Denshi USA, Inc. · Jul 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
K955642 · Nellcor Puritan Bennett, Inc. · Jul 1996