510(k) · Cleared
ClearedSpacelab Model 90845 PCMS Multidisclosure Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Oct 4, 1991 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Oct 4, 1991
- Review
- 87 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK913038 Spacelab Model 90845 PCMS Multidisclosure StationSpacelabs, Inc. · 1991
- 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 · cites it directly · 1 of its ownK963633 Ventnet; Central Monitoring StationPuritan Bennett Corp. · 1996
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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
- K963633Ventnet; Central Monitoring StationPuritan Bennett Corp. · 1996 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913038 | Spacelab Model 90845 PCMS Multidisclosure Station | Spacelabs, Inc. | 1991 | — |
| +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 |
| +1 | K963633 | Ventnet; Central Monitoring Station | Puritan Bennett Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
2 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 DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K913038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913038: Spacelab Model 90845 PCMS Multidisclosure Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913038
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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