510(k) · Cleared
Recalled · 2006Corometrics 5566AAX Noninvasive Blood Pressure Mod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 10, 1991 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it. It has been recalled once.
- Decided
- Jun 10, 1991
- Review
- 84 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK911310 Corometrics 5566AAX Noninvasive Blood Pressure ModGe Medical Systems Information Technologies · 1991
- Descendant · cites it directly · 16 of its ownK964770 Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 1997
- Descendant · 2 generations on · 10 of its ownK991739 Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- Descendant · 3 generations on · 6 of its ownK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
- Descendant · 4 generations on · 2 of its ownK150901 Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K964770Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 1997 · cites it directly16descendants
- K991739Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999 · 2 generations on10descendants
- K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008 · 3 generations on6descendants
- K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · 3 generations on5descendants
- K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911310 | Corometrics 5566AAX Noninvasive Blood Pressure Mod | Ge Medical Systems Information Technologies | 1991 | — |
| +1 | K964770 | Corometrics 120 Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 1997 | — |
| +2 | K991739 | Corometrics 120 Series Maternal/Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| +3 | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| +3 | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
| +4 | K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964770 | Corometrics 120 Series Maternal/Fetal Monitor | 1997 | 16 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2006 | Not classified | Z-1240-06 | Other | The tip of the catheter may separate from the body during operation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964770 (Ge Medical Systems Information Technologies, 1997) has gone furthest, with 16 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
https://510kreport.com/device/K911310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911310: Corometrics 5566AAX Noninvasive Blood Pressure Mod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911310
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026