510(k) · Cleared

Recalled · Class II · 2021

Multiple Patient Receiver, Model Org-9700A

K071058510(k) SpecialCleared Jun 29, 200774-day reviewClass II21 CFR 870.2910Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nihon Kohden America, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Jun 29, 2007 as substantially equivalent to K002068 (Nihon Kohden America, Inc., 2001) after a 74-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it. It has been recalled once.

Decided: Jun 29, 2007
Review: 74 days
Class: Class II
Product code: DRG
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K002068 (2001). 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK002068 ORG-9200ANihon Kohden America, Inc. · 2001
This deviceK071058 Multiple Patient Receiver, Model Org-9700ANihon Kohden America, Inc. · 2007
Descendant · cites it directly · 11 of its ownK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
Descendant · 2 generations on · 5 of its ownK082785 Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008
Descendant · 3 generations on · 4 of its ownK151080 Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · Recalled
Descendant · 2 generations on · 3 of its ownK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
Descendant · cites it directly · 2 of its ownK110809 Wireless Monitoring SystemCarefusion 303, Inc. · 2011

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 16 · See all

K080342Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008 · cites it directly11descendants
K082785Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008 · 2 generations on5descendants
K151080Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · 3 generations on4descendants
K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation · 2021 · 2 generations on3descendants
K110809Wireless Monitoring SystemCarefusion 303, Inc. · 2011 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002068	ORG-9200A	Nihon Kohden America, Inc.	2001	—
0 (this device)	K071058	Multiple Patient Receiver, Model Org-9700A	Nihon Kohden America, Inc.	2007	—
+1	K080342	Nihon Kohden Bedside Monitor, Model BSM-6000S Series	Nihon Kohden America, Inc.	2008	—
+2	K082785	Nihon Kohden Bedside Monitor, BSM 9100A Series	Nihon Kohden America, Inc.	2008	—
+3	K151080	Nihon Kohden CSM 1901 Bedside Monitor	Nihon Kohden	2015	1
+2	K201949	Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life…	Nihon Kohden Corporation	2021	—
+1	K110809	Wireless Monitoring System	Carefusion 303, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	3	0
2010	1	0
2011	2	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2020	1	0
2021	3	0
2022	2	0

FIG. 1 — Lineage of K071058, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DRG device

#1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K002068	ORG-9200A Summary page 1 …iological Signal, Radio frequency under 21 CFR 870.2910 * Legally Marketed Predicate: ORG-9700 and ORG-9200A Multiple Patient Receiver per 5 10(k) #K002068, commercial distribution certification dated February 8, 2001 Description and Intended Use: New ORG-9700A has the same…	Nihon Kohden America, Inc.	2001	—

What descends from it? (16)

See all 16

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080342	Nihon Kohden Bedside Monitor, Model BSM-6000S Series	Nihon Kohden America, Inc.	2008	11
K110809	Wireless Monitoring System	Carefusion 303, Inc.	2011	2
K102106	Nihon Khden Prefense Edns-9000 Series Central Nurse Station	Nihon Kohden Corp.	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 8, 2021	Class II	Z-1162-2021	Software design	Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K080342 (Nihon Kohden America, Inc., 2008) has gone furthest, with 11 descendants of its own.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	63	3	14
2008	5	74	0	9
2009	13	94	0	5
2010	10	68	0	13
2011	9	104	0	12
2012	12	103	0	9
2013	13	146	0	13
2014	10	177	0	97
2015	2	—	0	131
2016	2	—	0	182
2017	7	98	0	484
2018	6	220	0	166
2019	5	122	0	70
2020	6	159	0	82
2021	2	—	0	107
2022	6	287	0	43
2023	4	212	0	19
2024	3	125	0	26
2025	3	127	0	52
2026	2	—	1	—

What is it indicated for?

The ORG-9700A Multiple Patient Receiver is intended for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The device detects patient vital sign alarm conditions and includes an algorithm to detect cardiac arrhythmias. The intended use of the modified device has not changed as a result of the modifications. The device is available for use on all patient populations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071058 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071058: Multiple Patient Receiver, Model Org-9700A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071058

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026