510(k) · Cleared
ClearedCritiview, Model CRV3
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 Feb 28, 2007 as substantially equivalent to K051145 (Critisense, Ltd., 2006) and 1 other predicate after a 152-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 28, 2007
- Review
- 152 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K992529 (2000). 3 ancestors in all, the oldest K923538 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992529 | Tissue Spectroscope | Vital Medical, Ltd. | 2000 | — |
| −1 | K051145 | Critiview | Critisense, Ltd. | 2006 | — |
| 0 (this device) | K062977 | Critiview, Model CRV3 | Critisense, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (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 |
|---|---|---|---|
| * | K051145 | CritiviewSummary page 1…Catheter, retention type, balloon accessory (EZL) Device: CritiView Model CRV3 Predicate Devices: CritiView, CritiSense Ltd, K051145 Mallinckrodt - Foley with temperature - K923538 General Device Description: The CritiView device… | 2006 |
| * | K923538 | Mon-a-Therm Foley KitSummary page 1…CritiView Model CRV3 Predicate Devices: CritiView, CritiSense Ltd, K051145 Mallinckrodt - Foley with temperature - K923538 General Device Description: The CritiView device carries out certain in-vivo, spectroscopic measurements and displays them as… | 1993 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The CritiView Device 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. Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin, and urethra. Note that heart may not be used as the heart beating motion may not provide a…
Read the full statement (235 words)
The CritiView Device 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.
Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin, and urethra. Note that heart may not be used as the heart beating motion may not provide a reliable probe contact surface.
Duration of Use:
The CritiView has two probes--a pencil style probe and a Foley catheter probe-- which are in contact with the tissue to be measured / monitored. The optical portion of the probe (device) may be used continuously for up to eight (8) hours per twenty-four (24) hour period.
The Foley catheter can be left in place up to five (5) days.
Patient Population:
Pencil Style Probe: Neonate/infant, pediatric, and adult
Foley Catheter Probe: Hospitalized adults who are clinically indicated for a Foley catheter use.
Environment of use:
Hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions
Contraindications:
The Criti View should not be used on people that are hypersensitive to UV radiation. The device should not be used on patients taking photosensitizing drugs.
When monitoring the urethral wall tissue the device should not be used on patients with urinary tract or bladder infection or in any case when the patient clinical condition prevents the use of a Foley catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062977: Critiview, Model CRV3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062977
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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