510(k) · Cleared

Cleared

Smdie Device Interfacing System

K061590510(k) TraditionalCleared Jun 21, 200613-day reviewClass II21 CFR 870.2300

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

Siemens Medical Solutions Health Services Corporat · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Jun 21, 2006 as substantially equivalent to K012094 (Agilent Technologies, Inc., 2001) and 4 other predicates after a 13-day review. Its family tree reaches back 4 generations to 2000.

Decided: Jun 21, 2006
Review: 13 days
Class: Class II
Product code: MWI
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K000635 (2000). 8 ancestors in all, the oldest K980688 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK000635 Modification to HP M2376A Device Link SystemAgilent Technologies, Inc. · 2000
3 generations backK013019 DatacaptorCapsule Technologie · 2001 · Recalled
2 generations backK020197 Modification to DatacaptorCapsule Technologie · 2002 · Recalled
1 generation backK032142 DatacaptorCapsule Technologie · 2003 · Recalled
This deviceK061590 Smdie Device Interfacing SystemSiemens Medical Solutions Health Services Corporat · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000635	Modification to HP M2376A Device Link System	Agilent Technologies, Inc.	2000	—
−3	K013019	Datacaptor	Capsule Technologie	2001	2
−2	K020197	Modification to Datacaptor	Capsule Technologie	2002	2
−1	K032142	Datacaptor	Capsule Technologie	2003	2
0 (this device)	K061590	Smdie Device Interfacing System	Siemens Medical Solutions Health Services Corporat	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K061590, 2000–2006Source: 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 MWI? 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 MWI device

#1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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
*	K012094	Modification to Device Link System, Model M2376A Summary page 2 …Device Interfacing System substantially equivalent to the following predicate devices. M2367A Device Link System by Agilent Technologies, Inc. 510(k) #: K012094 Decision: Substantially Equivalent (SE) Unity Network ID by General Electric Medical Systems Information Technol…	Agilent Technologies, Inc.	2001	—
*	K021454	Unity Network ID Summary page 2 …510(k) #: K012094 Decision: Substantially Equivalent (SE) Unity Network ID by General Electric Medical Systems Information Technology 510(k) #: K021454 Decision: Substantially Equivalent (SE) DataCaptor by Capsule Technologie 510(k) #: K032142 Deci…	General Electric Medical Systems Information Techn	2002	—
*	K032142	Datacaptor Summary page 2 …cal Systems Information Technology 510(k) #: K021454 Decision: Substantially Equivalent (SE) DataCaptor by Capsule Technologie 510(k) #: K032142 Decision: Substantially Equivalent (SE) Integriti Patient Monitor by Alliance Instruments 510(k) #: K980…	Capsule Technologie	2003	2
*	K980688	Integriti Patient Monitor Summary page 2 …apsule Technologie 510(k) #: K032142 Decision: Substantially Equivalent (SE) Integriti Patient Monitor by Alliance Instruments 510(k) #: K980688 Decision: Substantially Equivalent (SE) Centra View Device Link System by ICU Data Systems, Inc. 510(k)…	Alliance Instruments	1999	—
*	K033283	Centra View Device Link System Summary page 2 …Instruments 510(k) #: K980688 Decision: Substantially Equivalent (SE) Centra View Device Link System by ICU Data Systems, Inc. 510(k) #: K033283 Decision: Substantially Equivalent (SE) Page 2 of 3…	Icu Datasystems, Inc.	2003	—

Also cleared against K012094: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
3 of the 8 ancestors have a recall of any class.
1 other device also cites its predicate K012094.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWI

4in 2025

2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007high 255 (2019) · low 42 (2007)2026

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

Recalls per year · MWI

9so far in 2026, the most since 2007

2007high 9 (2026) · low 0 (2016)2026

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

Adverse event reports per year · MWI

182in 2025

2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, 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	9	42	1	3
2008	9	49	1	3
2009	6	112	2	20
2010	17	58	2	17
2011	11	78	3	16
2012	13	104	5	31
2013	20	85	3	42
2014	16	148	6	30
2015	19	127	1	31
2016	12	165	0	51
2017	13	205	2	85
2018	11	217	0	158
2019	14	255	4	169
2020	8	138	0	110
2021	9	161	0	188
2022	5	231	2	168
2023	8	250	0	179
2024	10	202	5	120
2025	4	247	0	182
2026	6	239	9	—

What is it indicated for?

The SMDIE Device Interfacing System is indicated for data transfer between

standalone physiological monitors that collect noninvasive blood pressure,

temperature, and blood oxygenation level through external cuffs and

thermometers to external clinical information systems. The SMDIE is also

indicated for patient weight transfer between Scale-Tronix 5002 class

physician office scales. The SMDIE Device Interfacing System is not intended

for continuous vital sign monitoring purposes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061590 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061590: Smdie Device Interfacing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061590

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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