510(k) · Cleared
Recalled · Class II · 2020T12S Telemetry Transmitter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DQA Oximeter
Cleared on Sep 24, 2008 as substantially equivalent to K974149 (Mortara Instrument, Inc., 1998) and 2 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 24, 2008
- Review
- 91 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K933143 (1994). 22 ancestors in all, the oldest K781836 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 3 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 2 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 1 generation backK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
- This deviceK081800 T12S Telemetry TransmitterMortara Instrument, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK141020 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK182297 Surveyor S2Mortara Instrument, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK160685 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −3 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −2 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −1 | K983996 | Spacelabs Medical Ultraview Digital Telemtry System | Spacelabs Medical, Inc. | 1999 | — |
| 0 (this device) | K081800 | T12S Telemetry Transmitter | Mortara Instrument, Inc. | 2008 | — |
| +1 | K141020 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2014 | — |
| +2 | K182297 | Surveyor S2 | Mortara Instrument, Inc. | 2019 | — |
| +2 | K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974149 | Ambulatory X-12 Telemetry ModuleSummary page 1…marketed Mortara predicate device and is also substantially equivalent to other devices presently in distribution. * Mortara Ambulatory X-12 Telemetry Module, (K974149) · General Electric Apex Pro (K000779) * Spacelabs Telemetry (K983996) · Philips Intellivue (K993516)… | 1998 |
| * | K000779 | Apexpro Telemetry SystemSummary page 1…substantially equivalent to other devices presently in distribution. * Mortara Ambulatory X-12 Telemetry Module, (K974149) · General Electric Apex Pro (K000779) * Spacelabs Telemetry (K983996) · Philips Intellivue (K993516) Description: The T12S and T12 Telemetry Transmi… | 2000 |
| * | K983996 | Spacelabs Medical Ultraview Digital Telemtry SystemSummary page 1…presently in distribution. * Mortara Ambulatory X-12 Telemetry Module, (K974149) · General Electric Apex Pro (K000779) * Spacelabs Telemetry (K983996) · Philips Intellivue (K993516) Description: The T12S and T12 Telemetry Transmitters are non-invasive prescription devic… | 1999 |
| Kept off the family tree | K993516 | FDA’s K993516 is HP M2600A Viridia Telemetry System Our reading of the summary gave K993516, FDA’s number for HP M2600A Viridia Telemetry System (Hewlett-Packard Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Intellivue”. Kept off the family tree. Summary page 1…ortara Ambulatory X-12 Telemetry Module, (K974149) · General Electric Apex Pro (K000779) * Spacelabs Telemetry (K983996) · Philips Intellivue (K993516) Description: The T12S and T12 Telemetry Transmitters are non-invasive prescription devices positioned for typical use within a c… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141020 | Surveyor S4 Mobile Monitor | 2014 | 2 |
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-1813-2020 | 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K141020 (Mortara Instrument, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K974149.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The T12S Telemetry Transmitter is a non-invasive prescription device indicated for use as a radiofrequency physiological signal transmitter that acquires and delivers RF transmission of real-time electrocardiographic and pulse oximetry data obtained during physiologic stress exercise testing and ambulatory patient monitoring. indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the…
Read the full statement (191 words)
The T12S Telemetry Transmitter is a non-invasive prescription device
indicated for use as a radiofrequency physiological signal transmitter that acquires and delivers RF transmission of real-time electrocardiographic and pulse oximetry data obtained during physiologic stress exercise testing and ambulatory patient monitoring.
indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
The pulse oximetry sensor is indicated for use for continuous or spot monitoring of non-invasive arterial oxygen saturation monitoring.
indicated for use on hospital patients of any age where ambulatory monitoring of ECG and SpO2 data is done (e.g. patients in Coronary Care Units, Step-Down Units, Emergency Departments, stress testing or rehabilitation departments).
It is not designed for out of hospital transport.
It is not designed for use in highly invasive environments, such as an operating theatre.
The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081800: T12S Telemetry Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081800
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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