510(k) Report

510(k) · Cleared

Cleared

Pim 1.0 Laser Doppler Perfusion Imager

K920844510(k) TraditionalCleared Jul 21, 1992148-day reviewClass II21 CFR 870.2100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lisca Development AB · DPW Flowmeter, Blood, Cardiovascular

Cleared on Jul 21, 1992 after a 148-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 17 later devices descend from it.

Decided
Jul 21, 1992
Review
148 days
Class
Class II
Product code
DPW
Recalls
None
Predicates
0

17 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared1998: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2013: 3 descendants cleared2003: 1 descendant cleared2007: 3 descendants cleared2016: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK920844 Pim 1.0 Laser Doppler Perfusion ImagerLisca Development AB · 1992
  2. Descendant · cites it directly · 16 of its ownK980383 Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998
  3. Descendant · 2 generations on · 15 of its ownK032841 Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003
  4. Descendant · 3 generations on · 6 of its ownK063586 Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2007
  5. Descendant · cites it directly · 3 of its ownK120884 Pericam PsiPerimed AB · 2012
  6. Descendant · 3 generations on · 3 of its ownK063561 Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd. · 2007

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12007: 32012: 22013: 32014: 12016: 12017: 12018: 12019: 12020: 12024: 1
1998high 3 (2007) · low 0 (1999)2026

Most influential descendants

Showing 5 of 17 · See all
  • K980383Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998 · cites it directly16descendants
  • K032841Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003 · 2 generations on15descendants
  • K063586Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd. · 2007 · 3 generations on6descendants
  • K120884Pericam PsiPerimed AB · 2012 · cites it directly3descendants
  • K063561Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd. · 2007 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920844Pim 1.0 Laser Doppler Perfusion ImagerLisca Development AB1992—
+1K980383Mooorldi Laser Doppler ImagerMoor Instruments, Ltd.1998—
+2K032841Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd.2003—
+3K063586Moorflpi Full-Field Laser Perfusion ImagerMoor Instruments, Ltd.2007—
+1K120884Pericam PsiPerimed AB2012—
+3K063561Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200730
201220
201330
201410
201610
201710
201810
201910
202010
202410
FIG. 1 — Lineage of K920844, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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

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  2. #2 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980383Mooorldi Laser Doppler ImagerMoor Instruments, Ltd.199816
K120884Pericam PsiPerimed AB20123

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?

  • Of its descendants, K980383 (Moor Instruments, Ltd., 1998) has gone furthest, with 16 descendants of its own.

How does its category compare?

All DPW devices

DPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPW

3in 2025

2007: 12008: 12010: 22011: 42012: 12013: 22015: 32016: 12018: 22019: 32020: 22021: 22022: 32023: 12024: 12025: 32026 (partial year): 2
2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPW

119in 2025

2011: 89 days median2015: 275 days median2019: 169 days median2022: 136 days median2025: 119 days median
2007high 275 (2015) · low 89 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPW

1in 2025

2007: 42010: 12012: 12017: 12025: 1
2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DPW

6in 2025

2009: 12011: 12013: 32014: 82015: 122016: 12017: 22019: 32020: 42021: 62022: 12023: 22024: 42025: 6
2007high 12 (2015) · low 0 (2007)2025

MAUDE reports naming product code DPW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—40
20081—00
20090—01
20102—10
201148901
20121—10
20132—03
20140—08
20153275012
20161—01
20170—12
20182—00
2019316903
20202—04
20212—06
2022313601
20231—02
20241—04
2025311916
20262—0—
Cite this page

510(k) Report. “K920844: Pim 1.0 Laser Doppler Perfusion Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920844

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026