Cleared Traditional

K946175 - NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER

K946175 is an FDA 510(k) clearance for NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K946175 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
338d
Days
Class 2
Risk

K946175 is an FDA 510(k) clearance for the NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K946175

510(k) Number K946175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date November 22, 1995
Days to Decision 338 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 125d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 73
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K946175.
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749 · Philips Medical Systems · Nov 2002
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169 · Hewlett-Packard Co. · Dec 1999
AMBULATORY X-12 TELEMETRY MODULE
K974149 · Mortara Instrument, Inc. · Jan 1998
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
K945578 · Nihon Kohden America, Inc. · Nov 1995
SIEMENS 1481 T TRANSMITTER, ENHANCED
K945037 · Siemens Medical Solutions USA, Inc. · Mar 1995
CARDIOCAP DR-124 RECORDER
K910620 · Datex Division Instrumentarium Corp. · May 1991