510(k) · Cleared
ClearedElcam Vital Signs Wireless System (VSWS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elcam Medical Acal · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 16, 2012 as substantially equivalent to K090610 (Hospira, Inc., 2009) after a 171-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Jul 16, 2012
- Review
- 171 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K891104 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
- 3 generations backK974149 Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998 · Recalled
- 2 generations backK030795 Lifesyne SystemsGmp/Companies, Inc. · 2003 · Recalled
- 1 generation backK090610 Hospira Vital Signs Wireless Monitoring SystemHospira, Inc. · 2009
- This deviceK120253 Elcam Vital Signs Wireless System (VSWS)Elcam Medical Acal · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891104 | CD Telemetry Systems | Marquette Electronics, Inc. | 1989 | — |
| −3 | K974149 | Ambulatory X-12 Telemetry Module | Mortara Instrument, Inc. | 1998 | 1 |
| −2 | K030795 | Lifesyne Systems | Gmp/Companies, Inc. | 2003 | 3 |
| −1 | K090610 | Hospira Vital Signs Wireless Monitoring System | Hospira, Inc. | 2009 | — |
| 0 (this device) | K120253 | Elcam Vital Signs Wireless System (VSWS) | Elcam Medical Acal | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K090610 | Hospira Vital Signs Wireless Monitoring SystemSummary page 1…n Regulation: 21 CFR § 870.2910 Regulatory Class: 11 Identification of Legally Marketed Predicate Devices Hospira~ital Signs Wireless Monitoring System - K090610 Device Description Elcam Vital Signs Wireless System utilizes the Bluetooth® communications Protocol in order to eliminate the m… | 2009 |
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 23 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090610.
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. 2012, 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?
Elcam Vital Signs Wireless System is indicated for use on patients requiring pressure monitoring.
Elcamn Vital Signs Wireless System is intended to perform wireless transmigsion of pressure information to remote patient monitors from disposable pressure transducers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120253: Elcam Vital Signs Wireless System (VSWS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120253
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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