510(k) · Cleared
ClearedHICAT Air
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hicat GmbH · LLZ System, Image Processing, Radiological
Cleared on Nov 16, 2015 as substantially equivalent to K133320 (Sicat GmbH & Co. KG, 2014) after a 60-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Nov 16, 2015
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK053592 Simplant DR. JamesMaterialise NV · 2006
- 3 generations backK081402 Simplant Ortho ; Vistadent 3DMaterialise Dental NV · 2008
- 2 generations backK103723 Sicat Implant V1.2Sicat GmbH & Co. KG · 2011
- 1 generation backK133320 Sicat FunctionSicat GmbH & Co. KG · 2014
- This deviceK152661 HICAT AirHicat GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| −3 | K081402 | Simplant Ortho ; Vistadent 3D | Materialise Dental NV | 2008 | — |
| −2 | K103723 | Sicat Implant V1.2 | Sicat GmbH & Co. KG | 2011 | — |
| −1 | K133320 | Sicat Function | Sicat GmbH & Co. KG | 2014 | — |
| 0 (this device) | K152661 | HICAT Air | Hicat GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133320 | Sicat FunctionSummary page 4…er: 21 CFR 892.2050 Classification Class: Class II Product 3. PREDICATE DEVICES Primary Predicate: SICAT Function (K133320) Reference predicate: Dolphin Imaging 11.5 (K110430) 4. DEVICE DESCRIPTION HICAT Air is a pure software… | 2014 |
| † | K110430 | Dolphin Imaging | 2011 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K133320.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
HICAT Air is a software application for:
• Aiding diagnosis in the ear-nose-throat region
• Aiding treatment planning in the ear-nose-throat region
• Aiding comparisons of different treatment options
• Aiding treatment planning for oral appliances
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152661: HICAT Air.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152661
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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