510(k) · Cleared
ClearedInfinity Gateway Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jul 12, 2024 as substantially equivalent to K203579 (Draeger Medical Systems, Inc., 2022) after a 221-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Jul 12, 2024
- Review
- 221 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K900598 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- 5 generations backK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
- 4 generations backK014213 Siemens Infinity Gateway SuiteSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK030657 Siemens Infinity Gateway Suite, Model VF2Siemens Medical Solutions · 2003
- 2 generations backK043549 Infinity Gateway Suite, VF4Draeger Medical Systems, Inc. · 2005
- 1 generation backK203579 Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2022
- This deviceK233834 Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −5 | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder | Siemens Medical Solutions USA, Inc. | 1996 | — |
| −4 | K014213 | Siemens Infinity Gateway Suite | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K030657 | Siemens Infinity Gateway Suite, Model VF2 | Siemens Medical Solutions | 2003 | — |
| −2 | K043549 | Infinity Gateway Suite, VF4 | Draeger Medical Systems, Inc. | 2005 | — |
| −1 | K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022 | — |
| 0 (this device) | K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K203579 | Infinity Gateway SuiteSummary page 5…e: LNX Regulatory Class: II Regulation Number: §870.2300 III. Predicate Device The Infinity® Gateway Suite, VF9.0, cleared via K203579 on June 7, 2022. K233834… | 2022 |
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 34 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233834: Infinity Gateway Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233834
Report an extraction error
Are you the manufacturer?
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