510(k) · Cleared

Cleared

SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter

K970368510(k) TraditionalCleared May 6, 199795-day reviewClass II21 CFR 870.2700

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

Siemens Medical Solutions USA, Inc. · DQA Oximeter

Cleared on May 6, 1997 as substantially equivalent to K923682 (Hewlett-Packard Co., 1992) after a 95-day review. Its family tree reaches back 1 generation to 1992. 42 later devices descend from it.

Decided: May 6, 1997
Review: 95 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923682 (1992). 42 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
This deviceK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
Descendant · cites it directly · 41 of its ownK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
Descendant · cites it directly · 40 of its ownK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
Descendant · cites it directly · 39 of its ownK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
Descendant · cites it directly · 38 of its ownK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
Descendant · cites it directly · 37 of its ownK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

1999high 6 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 42 · See all

K991661Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999 · cites it directly41descendants
K012461Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001 · cites it directly40descendants
K020277Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002 · cites it directly39descendants
K022766Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002 · cites it directly38descendants
K033807Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDraeger Medical Systems, Inc. · 2004 · cites it directly37descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923682	Model M1032A Vuelink Interface Plug-in Module	Hewlett-Packard Co.	1992	—
0 (this device)	K970368	SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter	Siemens Medical Solutions USA, Inc.	1997	—
+1	K991661	Siemens Medical Information Bus (Mib) Protocol Converter	Siemens Medical Solutions USA, Inc.	1999	—
+1	K012461	Siemens Infinity Mib II Duo Protocol Converter	Siemens Medical Solutions USA, Inc.	2001	—
+1	K020277	Siemens Medical Infromation Bus (Mib II) Protocol Converter	Siemens Medical Solutions USA, Inc.	2002	—
+1	K022766	Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter	Siemens Medical Solutions USA, Inc.	2002	—
+1	K033807	Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter	Draeger Medical Systems, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	2	0
2004	1	0
2005	2	0
2006	1	0
2007	2	0
2010	1	0
2012	1	0
2013	1	0
2015	2	0
2018	1	0
2019	2	0
2020	3	0
2021	2	0
2022	3	0
2023	4	0
2024	6	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K970368, 1992–2026Source: 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 DQA? 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 DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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? (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
*	K923682	Model M1032A Vuelink Interface Plug-in Module Summary page 1 …r and 73 DQA Il 21CFR870.2060 conditioner 4: Predicate Device Identification: Hewlett-Packard Model M1032A Vuelink Interface Plug In Module cleared under 510(K) number: K923682 5. Device Description: The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generat…	Hewlett-Packard Co.	1992	—

Also cleared against K923682: 6 other devices →

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K991661	Siemens Medical Information Bus (Mib) Protocol Converter	Siemens Medical Solutions USA, Inc.	1999	41
K012461	Siemens Infinity Mib II Duo Protocol Converter	Siemens Medical Solutions USA, Inc.	2001	40
K020277	Siemens Medical Infromation Bus (Mib II) Protocol Converter	Siemens Medical Solutions USA, Inc.	2002	39
K022766	Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter	Siemens Medical Solutions USA, Inc.	2002	38
K033807	Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter	Draeger Medical Systems, Inc.	2004	37

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?

Its one ancestor has no recall.
Of its descendants, K991661 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 41 descendants of its own.
6 other devices also cite its predicate K923682.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970368 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970368: SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970368

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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