Cleared Special

MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A (K071058) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071058 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
74d
Days
Class 2
Risk

K071058 is an FDA 510(k) clearance for the MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K071058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2007
Decision Date June 29, 2007
Days to Decision 74 days
Submission Type Special
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
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 54
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K071058.
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
K101834 · 3M Company · Sep 2010
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
K100427 · Taidoc Technology Corporation · May 2010
FORA TELEHEALTH SYSTEM
K083046 · Taidoc Technology Corporation · Jan 2009
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169 · Hewlett-Packard Co. · Dec 1999
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
K946175 · Nihon Kohden America, Inc. · Nov 1995
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
K945578 · Nihon Kohden America, Inc. · Nov 1995