510(k) Report

510(k) · Cleared

Cleared

Aimago Easyldi Microcirculation Camera

K121429510(k) TraditionalCleared Aug 10, 201288-day reviewClass II21 CFR 870.2120

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

Aimago SA · DPT Probe, Blood-Flow, Extravascular

Cleared on Aug 10, 2012 as substantially equivalent to K063561 (Moor Instruments, Ltd., 2007) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.

Decided
Aug 10, 2012
Review
88 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. 2 later devices descend from it, 1 citing it directly.

  1. Root · 4 generations backK905232 Moor Laser Blood Flow Monitor MBF3Moor Instruments, Ltd. · 1991
  2. 3 generations backK980383 Mooorldi Laser Doppler ImagerMoor Instruments, Ltd. · 1998
  3. 2 generations backK032841 Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd. · 2003
  4. 1 generation backK063561 Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd. · 2007
  5. This deviceK121429 Aimago Easyldi Microcirculation CameraAimago SA · 2012
  6. Descendant · cites it directly · 1 of its ownK123216 Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm)…Aimago SA · 2013
  7. Descendant · 2 generations on · 0 of its ownK163339 Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc. · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K123216Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…Aimago SA · 2013 · cites it directly1descendant
  • K163339Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K905232Moor Laser Blood Flow Monitor MBF3Moor Instruments, Ltd.1991—
−3K980383Mooorldi Laser Doppler ImagerMoor Instruments, Ltd.1998—
−2K032841Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRMoor Instruments, Ltd.2003—
−1K063561Moorldls Laser Doppler Line ScannerMoor Instruments, Ltd.2007—
0 (this device)K121429Aimago Easyldi Microcirculation CameraAimago SA2012—
+1K123216Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy…Aimago SA2013—
+2K163339Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201710
FIG. 1 — Lineage of K121429, 1991–2017Source: 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), 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. #1 K233076 Laser Speckle Imaging System (RFLSI CZW)score 8.6 · 5 generations · no Class I recall
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K063561Moorldls Laser Doppler Line Scanner
Summary page 1
…Cardiovascular Predicate Device: Substantial Equivalence is claimed with the predicate devices: * moorLDLS Laser Doppler Line Scanner (K063561), and the * moorLDl2-IR Infrared Laser Doppler Imager (K032841) both manufactured by MOOR INSTRUMENTS LTD., Mil…
Moor Instruments, Ltd.2007—
*K032841Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IR
Summary page 1
…alence is claimed with the predicate devices: * moorLDLS Laser Doppler Line Scanner (K063561), and the * moorLDl2-IR Infrared Laser Doppler Imager (K032841) both manufactured by MOOR INSTRUMENTS LTD., Millwey, Axminster, Devon (UK). Both the new and the predicate device…
Moor Instruments, Ltd.2003—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123216Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…Aimago SA20131

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, K123216 (Aimago SA, 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DPT devices

DPT 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

2007: 32009: 12012: 22013: 32014: 32015: 12016: 12017: 12024: 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPT

201in 2014

2007: 55 days median2013: 108 days median2014: 201 days median
2007high 201 (2014) · low 55 (2007)2026

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

Recalls per year · DPT

22in 2024

2024: 22
2007high 22 (2024) · low 0 (2007)2026

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

Adverse event reports per year · DPT

52in 2025

2007: 52008: 12009: 32010: 32011: 32012: 12014: 52018: 32019: 12020: 32021: 132022: 462023: 212024: 1692025: 52
2007high 169 (2024) · low 0 (2013)2025

MAUDE reports naming product code DPT, 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
200735505
20080—01
20091—03
20100—03
20110—03
20122—01
2013310800
2014320105
20151—00
20161—00
20171—00
20180—03
20190—01
20200—03
20210—013
20220—046
20230—021
20241—22169
20250—052
20260—0—

What is it indicated for?

The Aimago EasyLDi Microcirculation Camera is intended for blood flow measurements in the microcirculation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K121429: Aimago Easyldi Microcirculation Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121429

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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