510(k) · Cleared
Cleared12 RL Algorithm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Aug 4, 2006 as substantially equivalent to K992595 (Hewlett-Packard GmbH, 1999) and 2 other predicates after a 178-day review. Its family tree reaches back 5 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 4, 2006
- Review
- 178 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K946306 (1995). 33 ancestors in all, the oldest K872781 (1987). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 4 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK030738 Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2003
- This deviceK060307 12 RL AlgorithmGe Medical Systems Information Technologies · 2006
- Descendant · cites it directly · 4 of its ownK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- Descendant · 2 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK151812 Patient Monitors Various ModelsPhilips Medical Systems · 2016
- Descendant · 2 generations on · 0 of its ownK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010 · cites it directly4descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on1descendant
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 2 generations on0descendants
- K151812Patient Monitors Various ModelsPhilips Medical Systems · 2016 · 2 generations on0descendants
- K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −4 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K030738 | Siemens Multiview Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K060307 | 12 RL Algorithm | Ge Medical Systems Information Technologies | 2006 | — |
| +1 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| +2 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
| +2 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | — |
| +2 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement…Summary page 1…21 CFR 870.2920 Transmitters and Receivers, Electrocardiograph, Telephone 74DXH Predicate Device: 1 K992595 1 EASI 1 Philips 2 K030738 2 TruST 2 Siemens… | 1999 |
| * | K030738 | Siemens Multiview Infinity Telemetry SystemSummary page 1…Electrocardiograph, Telephone 74DXH Predicate Device: 1 K992595 1 EASI 1 Philips 2 K030738 2 TruST 2 Siemens 3 K964750 3 Marquette Eagle 4000 3 GE Medical Systems… | 2003 |
| * | K964750 | Eagle 4000 Patient MonitorSummary page 1…ice: 1 K992595 1 EASI 1 Philips 2 K030738 2 TruST 2 Siemens 3 K964750 3 Marquette Eagle 4000 3 GE Medical Systems In format… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | 2010 | 4 |
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 11 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 33 ancestors has a recall.
- Of its descendants, K101521 (Philips Medical Systems, 2010) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K992595.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The GE 12RL program generates a 12-lead ECG report from a subset of the electrodes used to acquire a standard '12 lead ECG. Four of the precordial channels of the 12-lead ECG (V2, V3, V4, V6) are not acquired from the patient; rather, they are reconstructed from information that is directly recorded in the other channels of the 12-lead ECG. The four signals generated by the GE 12RL program are similar but not identical to the standard 12-lead ECG. All…
Read the full statement (165 words)
The GE 12RL program generates a 12-lead ECG report from a subset of the electrodes used to acquire a standard '12 lead ECG. Four of the precordial channels of the 12-lead ECG (V2, V3, V4, V6) are not acquired from the patient; rather, they are reconstructed from information that is directly recorded in the other channels of the 12-lead ECG.
The four signals generated by the GE 12RL program are similar but not identical to the standard 12-lead ECG. All ECG data generated via 12RL are clearly identified as to which channels have been synthesized.
The GE 12RL program is intended for use in a monitoring environment. Computerized measurements may be generated from these data; however, a computerized interpretation will not.
The product is intended for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
The product is to be uscd in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060307: 12 RL Algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060307
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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