510(k) · Cleared
ClearedDirectpath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybernet Systems Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 10, 2012 as substantially equivalent to K093810 (Kgt, Inc., 2010) and 1 other predicate after a 56-day review. Its family tree reaches back 10 generations to 1993. 1 of the 31 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 10, 2012
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K926514 (1993). 30 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 6 generations between
- 3 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 2 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK093810 BF-NaviKgt, Inc. · 2010
- This deviceK121449 DirectpathCybernet Systems Co., Ltd. · 2012
Show all 10 generations
- Root · 10 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 9 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 8 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 7 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 6 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 5 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 4 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 3 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 2 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK093810 BF-NaviKgt, Inc. · 2010
- This deviceK121449 DirectpathCybernet Systems Co., Ltd. · 2012
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…4 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −9 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −8 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −7 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −6 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −5 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −4 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −3 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −2 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −1 | K093810 | BF-Navi | Kgt, Inc. | 2010 | — |
| 0 (this device) | K121449 | Directpath | Cybernet Systems Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K093810 | BF-NaviSummary page 1…choscopic Navigator Classification Name: Computed tomography x-ray system Classification Regulation: 892.1750 Product Code: JAK 5. Predicate Devices KGT Inc. - Bf-NAVI K09381 0 VIDAS Diagnostics - VIDA Pulmonary Workstation 2 (PW2) K083227 Cybernet Systems Co., Ltd. Traditional 510(k) Prem… | 2010 |
| * | K083227 | Vida Pulmonary Workstation 2 (PW2)Summary page 1…ay system Classification Regulation: 892.1750 Product Code: JAK 5. Predicate Devices KGT Inc. - Bf-NAVI K09381 0 VIDAS Diagnostics - VIDA Pulmonary Workstation 2 (PW2) K083227 Cybernet Systems Co., Ltd. Traditional 510(k) Premarket Submission Direct Path 6. Device Description The DirectP… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121449: Directpath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121449
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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