Cleared Traditional

K965158 - HEART PROTECTOR (VER 1996)

K965158 is an FDA 510(k) clearance for HEART PROTECTOR (VER 1996), manufactured by N.P.N.T., Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K965158 · N.P.N.T., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
351d
Days
Class 2
Risk

K965158 is an FDA 510(k) clearance for the HEART PROTECTOR (VER 1996). Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by N.P.N.T., Inc. (Downsview, Ontario, CA). The FDA issued a Cleared decision on December 9, 1997 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 N.P.N.T., Inc. devices

FDA 510(k) Submission Details - K965158

510(k) Number K965158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date December 09, 1997
Days to Decision 351 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 125d · This submission: 351d
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 203
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K965158.
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
K974581 · Invivo Research, Inc. · Oct 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · Datascope Corp. · Jun 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · Nihon Kohden America, Inc. · Jan 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787 · Alexander Mfg. Co. · Oct 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
K972789 · Alexander Mfg. Co. · Oct 1997
EAGLE 3000 PATIENT MONITOR
K952474 · Marquette Electronics, Inc. · Oct 1995