510(k) · Cleared
ClearedModel Acuity Central Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protocol Systems, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Dec 5, 1994 after a 362-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.
- Decided
- Dec 5, 1994
- Review
- 362 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
64 later devices descend from it, 2 citing it directly.
- This deviceK935846 Model Acuity Central StationProtocol Systems, Inc. · 1994
- Descendant · cites it directly · 63 of its ownK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- Descendant · cites it directly · 38 of its ownK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 18 of its ownK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- Descendant · 4 generations on · 17 of its ownK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · cites it directly63descendants
- K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · cites it directly38descendants
- K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 2 generations on20descendants
- K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · 3 generations on18descendants
- K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935846 | Model Acuity Central Station | Protocol Systems, Inc. | 1994 | — |
| +1 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| +1 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| +2 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +3 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| +4 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (64)
See all 642 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K022453 (Welch Allyn Protocol, Inc., 2002) has gone furthest, with 63 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K935846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935846: Model Acuity Central Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935846
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026