510(k) · Cleared
ClearedPacific Communications Model 1100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accucore, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jan 30, 1995 after a 272-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jan 30, 1995
- Review
- 272 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK942147 Pacific Communications Model 1100Accucore, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK962473 (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…Data Critical Corporation · 1997
- Descendant · 2 generations on · 3 of its ownK020524 Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- Descendant · 3 generations on · 2 of its ownK031760 Viewpoint Telemetry SystemDatascope Corp. · 2003 · Recalled
- Descendant · 4 generations on · 1 of its ownK142601 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · Recalled
- Descendant · 5 generations on · 0 of its ownK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K962473(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and…Data Critical Corporation · 1997 · cites it directly5descendants
- K020524Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002 · 2 generations on3descendants
- K031760Viewpoint Telemetry SystemDatascope Corp. · 2003 · 3 generations on2descendants
- K142601Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · 4 generations on1descendant
- K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942147 | Pacific Communications Model 1100 | Accucore, Inc. | 1995 | — |
| +1 | K962473 | (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory… | Data Critical Corporation | 1997 | — |
| +2 | K020524 | Patientnet Monitoring System | General Electric Medical Systems Information Techn | 2002 | 1 |
| +3 | K031760 | Viewpoint Telemetry System | Datascope Corp. | 2003 | 5 |
| +4 | K142601 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co. | 2014 | 1 |
| +5 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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? (9)
4 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, K962473 (Data Critical Corporation, 1997) has gone furthest, with 5 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/K942147 · printed Nov 5, 2026
Cite this page
510(k) Report. “K942147: Pacific Communications Model 1100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K942147
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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