510(k) · Cleared
ClearedHospira Vital Signs Wireless Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Mar 13, 2009 as substantially equivalent to K053016 (Edwards Lifesciences, LLC, 2005) and 1 other predicate after a 7-day review. Its family tree reaches back 3 generations to 1989. 9 later devices descend from it.
- Decided
- Mar 13, 2009
- Review
- 7 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K891104 (1989). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
- 2 generations backK974149 Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998 · Recalled
- 1 generation backK030795 Lifesyne SystemsGmp/Companies, Inc. · 2003 · Recalled
- This deviceK090610 Hospira Vital Signs Wireless Monitoring SystemHospira, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK212160 SimpleSENSE PlatformNanowear, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK243981 Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · cites it directly6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 2 generations on5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 3 generations on3descendants
- K212160SimpleSENSE PlatformNanowear, Inc. · 2021 · 4 generations on1descendant
- K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891104 | CD Telemetry Systems | Marquette Electronics, Inc. | 1989 | — |
| −2 | K974149 | Ambulatory X-12 Telemetry Module | Mortara Instrument, Inc. | 1998 | 1 |
| −1 | K030795 | Lifesyne Systems | Gmp/Companies, Inc. | 2003 | 3 |
| 0 (this device) | K090610 | Hospira Vital Signs Wireless Monitoring System | Hospira, Inc. | 2009 | — |
| +1 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +2 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +3 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +4 | K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021 | — |
| +4 | K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K053016 | Wireless Physiologic Monitoring SystemSummary page 1…s Wireless Monitoring System Proposed Device: 5. Predicate Devices: Edwards LifeSciences Wireless Physiologic Monitoring System (K053016) GMP/ Wireless Medicine LifeSynCTM System (K030795) 6. Proposed Device Description: The Hospi… | 2005 |
| * | K030795 | Lifesyne SystemsSummary page 1…wards LifeSciences Wireless Physiologic Monitoring System (K053016) GMP/ Wireless Medicine LifeSynCTM System (K030795) 6. Proposed Device Description: The Hospira Vital Signs Wireless Monitoring System utilizes the Bluetooth® communicati… | 2003 |
What descends from it? (9)
3 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K142476 (Healthwatch, Ltd., 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K053016.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Hospira Vital Signs Wireless Monitoring System is indicated for use on patients requiring pressure monitoring. Hospira Vital Signs Wireless Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090610 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090610: Hospira Vital Signs Wireless Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090610
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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