510(k) · Cleared
ClearedModification to Cma 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 Jan 14, 2011 as substantially equivalent to K071984 (Cma Microdialysis AB, 2008) after a 175-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Jan 14, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K813459 (1982). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
- 5 generations backK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
- 4 generations backK980380 Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend…Diametrics Medical, Ltd. · 1999
- 3 generations backK020285 Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2002
- 2 generations backK060554 Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2006
- 1 generation backK071984 Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2008
- This deviceK102077 Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K813459 | Reusable & Disposable Temp. Probes | Electromedics, Inc. | 1982 | — |
| −5 | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | Camino Neurocare, Inc. | 1996 | 2 |
| −4 | K980380 | Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+… | Diametrics Medical, Ltd. | 1999 | — |
| −3 | K020285 | Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | 2002 | — |
| −2 | K060554 | Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | 2006 | — |
| −1 | K071984 | Modification to Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | 2008 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K071984 | Modification to Cma Cerebral Tissue Monitoring SystemSummary page 1…21 CFR 882.1620 Classication Panel: Neurology Device Panel 5. Predicate device CMIA Cerebral Tissue Monitoring System, K071984 Previous submissions modified: CMIA Cerebral Tissue Monitoring System, K060554 CMA 600 Cerebral Tissue M… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 14 ancestors have a recall of any class.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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, pyruvate, glycerol and glutamate 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 isehemia or hypoxia is a concern.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102077: Modification to 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/K102077
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