510(k) · Cleared
Recalled · Class II · 2020Ambulatory X-12 Telemetry Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jan 8, 1998 as substantially equivalent to K920429 (Hewlett-Packard Co., 1993) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 1989. 122 later devices descend from it. It has been recalled once.
- Decided
- Jan 8, 1998
- Review
- 65 days
- Class
- Class II
- Product code
- DRG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891104 (1989). 2 ancestors in all. 122 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
- This deviceK974149 Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998
- Descendant · cites it directly · 109 of its ownK030795 Lifesyne SystemsGmp/Companies, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · 2 generations on · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
- Descendant · 3 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- Descendant · 4 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K030795Lifesyne SystemsGmp/Companies, Inc. · 2003 · cites it directly109descendants
- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · 2 generations on99descendants
- K113054EquivitalHidalgo Limited · 2012 · 2 generations on71descendants
- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 3 generations on70descendants
- K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 4 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891104 | CD Telemetry Systems | Marquette Electronics, Inc. | 1989 | — |
| 0 (this device) | K974149 | Ambulatory X-12 Telemetry Module | Mortara Instrument, Inc. | 1998 | — |
| +1 | K030795 | Lifesyne Systems | Gmp/Companies, Inc. | 2003 | 3 |
| +2 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +2 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +3 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| +4 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 15 | 0 |
| 2024 | 12 | 0 |
| 2025 | 16 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K920429 | Modified Model M1403A Telemetry Monitoring SystemSummary page 3…es Tabular Comparison of Competitor’s Devices Features Mortara Instrument Ambulatory X-12 Intended Use Hewlett Packard M1403A Digital UHF Telemetry System 510k #: (K920429) HP M1400A Transmitter Transmit 12 leads of patient data by a digital radio transmission. Marquette Electronics CD-Telemetry L… | 1993 |
| * | K891104 | CD Telemetry SystemsSummary page 3…etry System 510k #: (K920429) HP M1400A Transmitter Transmit 12 leads of patient data by a digital radio transmission. Marquette Electronics CD-Telemetry LAN 510k #: (K891104) CD Telemetry Transmitter Transmit 2 leads of patient data by a digital radio transmission to a receiver over an antenna networ… | 1989 |
What descends from it? (122)
See all 1227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030795 | Lifesyne Systems | 2003 | 109 |
| K150289 | Cardioline HD+ | 2015 | 3 |
| K081800 | T12S Telemetry Transmitter | 2008 | 3 |
| K141020 | Surveyor S4 Mobile Monitor | 2014 | 2 |
| K093211 | Carecenter MD | 2010 | 1 |
| K032882 | Recom Battery-Operated Ambulatory Digital Wireless Ecg Monitor, Model 100 | 2004 | 0 |
| K993643 | Nexsystem Ambulatory Patient Monitor Model Nex 100 | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2020 | Class II | Z-1814-2020 | Device Design | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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?
The device is intended to be used as a radiofrequency physiological signal transmitter and receiver to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another. The received signal is reconditioned by the device into its original format so that it can be displayed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974149: Ambulatory X-12 Telemetry Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974149
Report an extraction error
Are you the manufacturer?
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