510(k) · Cleared
ClearediCertainty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rfpi · DPW Flowmeter, Blood, Cardiovascular
Cleared on Dec 14, 2018 as substantially equivalent to K120884 (Perimed AB, 2012) after a 214-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Dec 14, 2018
- Review
- 214 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K905232 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK905232 Moor Laser Blood Flow Monitor MBF3Moor Instruments, Ltd. · 1991
- 4 generations backK980383 Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998
- 3 generations backK032841 Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003
- 2 generations backK063586 Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2007
- 1 generation backK120884 Pericam PsiPerimed AB · 2012
- This deviceK181269 iCertaintyRfpi · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K905232 | Moor Laser Blood Flow Monitor MBF3 | Moor Instruments, Ltd. | 1991 | — |
| −4 | K980383 | Mooorldi Laser Doppler Imager | Moor Instruments, Ltd. | 1998 | — |
| −3 | K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IR | Moor Instruments, Ltd. | 2003 | — |
| −2 | K063586 | Moorflpi Full-Field Laser Perfusion Imager | Moor Instruments, Ltd. | 2007 | — |
| −1 | K120884 | Pericam Psi | Perimed AB | 2012 | — |
| 0 (this device) | K181269 | iCertainty | Rfpi | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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.
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 27 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K120884.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 iCertainty System is intended for non-invasive two-dimensional imaging as an adjunctive method for
evaluation of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181269 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181269: iCertainty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181269
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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