510(k) · Cleared
ClearedCritiview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Critisense, Ltd. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Jan 18, 2006 as substantially equivalent to K992529 (Vital Medical, Ltd., 2000) after a 259-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jan 18, 2006
- Review
- 259 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992529 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K062977Critiview, Model CRV3Critisense, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992529 | Tissue Spectroscope | Vital Medical, Ltd. | 2000 | — |
| 0 (this device) | K051145 | Critiview | Critisense, Ltd. | 2006 | — |
| +1 | K062977 | Critiview, Model CRV3 | Critisense, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 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 |
|---|---|---|---|
| * | K992529 | Tissue SpectroscopeSummary page 1…Fluorometer for clinical use (KHO) Device: CritiView Predicate Devices: Tissue Spectroscope, Vital Medical - K992529 (Vital Medical became CritiSense). Device Description: The CritiView device carries out… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062977 | Critiview, Model CRV3 | 2007 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K062977 (Critisense, Ltd., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change provide information on tissue metabolic activity. The CritiView uses a pencil style probe which is in contact with the tissue(s) to be measured / monitored. The device may be used for up to eight (8) hours per twenty-four (24) hour…
Read the full statement (120 words)
CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change provide information on tissue metabolic activity.
The CritiView uses a pencil style probe which is in contact with the tissue(s) to be measured / monitored. The device may be used for up to eight (8) hours per twenty-four (24) hour period.
Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin. Note that heart may not be used, as the heart beating motion may not provide a reliable probe contact surface.
Environment of use include - hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051145: Critiview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051145
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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