510(k) · Cleared
ClearedPericam Psi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimed AB · DPT Probe, Blood-Flow, Extravascular
Cleared on Jul 3, 2012 as substantially equivalent to K920844 (Lisca Development AB, 1992) and 1 other predicate after a 102-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Jul 3, 2012
- Review
- 102 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K905232 (1991). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK905232 Moor Laser Blood Flow Monitor MBF3Moor Instruments, Ltd. · 1991
- 3 generations backK980383 Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998
- 2 generations backK032841 Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003
- 1 generation backK063586 Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2007
- This deviceK120884 Pericam PsiPerimed AB · 2012
- Descendant · cites it directly · 1 of its ownK182494 FlowMet-RLaser Associated Sciences, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK192966 FlowMetLaser Associated Sciences, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK181269 iCertaintyRfpi · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905232 | Moor Laser Blood Flow Monitor MBF3 | Moor Instruments, Ltd. | 1991 | — |
| −3 | K980383 | Mooorldi Laser Doppler Imager | Moor Instruments, Ltd. | 1998 | — |
| −2 | K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IR | Moor Instruments, Ltd. | 2003 | — |
| −1 | K063586 | Moorflpi Full-Field Laser Perfusion Imager | Moor Instruments, Ltd. | 2007 | — |
| 0 (this device) | K120884 | Pericam Psi | Perimed AB | 2012 | — |
| +1 | K182494 | FlowMet-R | Laser Associated Sciences, Inc. | 2019 | — |
| +2 | K192966 | FlowMet | Laser Associated Sciences, Inc. | 2020 | — |
| +1 | K181269 | iCertainty | Rfpi | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 DPT? 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 DPT device
- #1 K233076 Laser Speckle Imaging System (RFLSI CZW)score 8.6 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K920844 | Pim 1.0 Laser Doppler Perfusion ImagerSummary page 3…PC-software generates colour-coded flow maps of the tissue perfusion from the contrast images. Comparison to the predicate device K920844, PIM Laser Doppler Perfusion Imager - Laser safety The predicate device, PIM Laser… | 1992 |
| * | K063586 | Moorflpi Full-Field Laser Perfusion ImagerSummary page 5…rding lEG 60825-1:2007. The new device all 'ws fast acquisition rates for larger measurement areas. Comparison to the predicate device K063586, moorFLPI Full Field Laser Perfusion Imager- - Laser safety Both instrument… | 2007 |
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 21 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K182494 (Laser Associated Sciences, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K920844.
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DPT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DPT
201in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPT
22in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPT
52in 2025
MAUDE reports naming product code DPT, 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 | 3 | 55 | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 3 | 108 | 0 | 0 |
| 2014 | 3 | 201 | 0 | 5 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 21 |
| 2024 | 1 | — | 22 | 169 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PeriCam PSI is intended for non-invasive two-dimensional imaging of
peripheral tissue blood perfusion.
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/K120884 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120884: Pericam Psi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120884
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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