510(k) · Cleared
ClearedAida Compact II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 7, 2005 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Sep 7, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK052159 Aida Compact II SystemKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK103308 Aida HD Connect with Smartscreen / Blu-Ray Drive / Smartscreen with…KARL STORZ Endoscopy-America, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103308Aida HD Connect with Smartscreen / Blu-Ray Drive / Smartscreen with Blu-Ray DriveKARL STORZ Endoscopy-America, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052159 | Aida Compact II System | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +1 | K103308 | Aida HD Connect with Smartscreen / Blu-Ray Drive / Smartscreen with Blu-Ray… | KARL STORZ Endoscopy-America, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103308 | Aida HD Connect with Smartscreen / Blu-Ray Drive / Smartscreen with Blu-Ray Drive | 2011 | 0 |
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, K103308 (KARL STORZ Endoscopy-America, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
This device is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nurses Station. The Advanced Image Archiving Compact II System (AIDA Compact II) is a Windows based archiving and data documentation software for still images, video and audio sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images…
Read the full statement (156 words)
This device is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nurses Station. The Advanced Image Archiving Compact II System (AIDA Compact II) is a Windows based archiving and data documentation software for still images, video and audio sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis. It offers an optional Windows® based solution to communicate with other picture archival and communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA Compact II System, the Storz Application Manager software (SAM) enables the selection and integration of AIDA functions with various compatible applications, such as the Storz Communication Bus (SCB) or other third party image capturing devices.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052159: Aida Compact II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052159
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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