510(k) · Cleared
ClearedCma Cerebral Tissue Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cma Microdialysis AB · GWM Device, Monitoring, Intracranial Pressure
Cleared on Oct 23, 2002 as substantially equivalent to K002765 (Integra Neurosciences, 2000) and 1 other predicate after a 268-day review. Its family tree reaches back 3 generations to 1982. 3 later devices descend from it.
- Decided
- Oct 23, 2002
- Review
- 268 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K813459 (1982). 11 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
- 2 generations backK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
- 1 generation backK980380 Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend…Diametrics Medical, Ltd. · 1999
- This deviceK020285 Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2002
- Descendant · cites it directly · 2 of its ownK060554 Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2006
- Descendant · cites it directly · 1 of its ownK071984 Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2008
- Descendant · 2 generations on · 0 of its ownK102077 Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2011
Most influential descendants
Showing 3 of 3 · See all- K060554Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2006 · cites it directly2descendants
- K071984Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2008 · cites it directly1descendant
- K102077Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813459 | Reusable & Disposable Temp. Probes | Electromedics, Inc. | 1982 | — |
| −2 | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | Camino Neurocare, Inc. | 1996 | 2 |
| −1 | K980380 | Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+… | Diametrics Medical, Ltd. | 1999 | — |
| 0 (this device) | K020285 | Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | 2002 | — |
| +1 | K060554 | Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | 2006 | — |
| +1 | K071984 | Modification to Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | 2008 | — |
| +2 | K102077 | Modification to Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 GWM? 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 GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 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 |
|---|---|---|---|
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 1…me: Brain IschemidHypoxia Monitoring System Classification Name: Intracranial Pressure Monitoring Device 3. DEVICE PREDICATE 0 K002765, LlCOX Brain Oxygen Monitoring system, CMP@Monitor and IMC@ Systems 0 K980380, CODMAN Neurotrend Multiparameter… | 2000 |
| * | K980380 | Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Summary page 1…ressure Monitoring Device 3. DEVICE PREDICATE 0 K002765, LlCOX Brain Oxygen Monitoring system, CMP@Monitor and IMC@ Systems 0 K980380, CODMAN Neurotrend Multiparameter Sensor 4. INTENDED USE The CMA Cerebral Tissue Monitoring System measures intracran… | 1999 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K060554 (Cma Microdialysis AB, 2006) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K002765.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, 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 | 2 | — | 0 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, and pyruvate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020285: Cma Cerebral Tissue Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020285
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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