510(k) · Cleared
ClearedLungpoint Atv Planning and Navigation Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Broncus Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 26, 2014 as substantially equivalent to K112051 (Broncus Technologies, Inc., 2011) and 2 other predicates after a 113-day review. Its family tree reaches back 14 generations to 1993. 1 of the 77 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 26, 2014
- Review
- 113 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K926514 (1993). 76 ancestors in all, the oldest K852353 (1985). No later device cites it as a predicate yet. 1 of the 77 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 10 generations between
- 3 generations backK102604 I-Logic Inreach SystemSuperdimension, Ltd. · 2010
- 2 generations backK110093 Superdimension Marker Delivery KitSuperdimension, Inc. · 2011
- 1 generation backK112051 Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc. · 2011
- This deviceK133385 Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc. · 2014
Show all 14 generations
- Root · 14 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 13 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 12 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 11 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 10 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 9 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 8 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 7 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 6 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 5 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 4 generations backK092365 Inreach System, Model AAS00161-02Superdimension, Ltd. · 2009
- 3 generations backK102604 I-Logic Inreach SystemSuperdimension, Ltd. · 2010
- 2 generations backK110093 Superdimension Marker Delivery KitSuperdimension, Inc. · 2011
- 1 generation backK112051 Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc. · 2011
- This deviceK133385 Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc. · 2014
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…5 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −13 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −12 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −11 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −10 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −9 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −8 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −7 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −6 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −5 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −4 | K092365 | Inreach System, Model AAS00161-02 | Superdimension, Ltd. | 2009 | — |
| −3 | K102604 | I-Logic Inreach System | Superdimension, Ltd. | 2010 | — |
| −2 | K110093 | Superdimension Marker Delivery Kit | Superdimension, Inc. | 2011 | — |
| −1 | K112051 | Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software | Broncus Technologies, Inc. | 2011 | — |
| 0 (this device) | K133385 | Lungpoint Atv Planning and Navigation Software | Broncus Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 1 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K112051 | Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareSummary page 1…ket submission include: Nahe 45OkSbrit 51(kNubr. LungPoint Planning and Broncus Medical, #1(112051, #1093423, Virtual Bronchoscopic Inc.* Navigation (VBN) System EP Navigator Philips… | 2011 |
| * | K093423 | Lungpoint Procedure PlanningSummary page 1…sion include: Nahe 45OkSbrit 51(kNubr. LungPoint Planning and Broncus Medical, #1(112051, #1093423, Virtual Bronchoscopic Inc.* Navigation (VBN) System EP Navigator Philips Medical… | 2009 |
| * | K101311 | EP Navigator R3Summary page 1…#1(112051, #1093423, Virtual Bronchoscopic Inc.* Navigation (VBN) System EP Navigator Philips Medical #K(101311 *NOTE: Broncus Technologies, Inc changed their name to Broncus Medical, Inc in June 2012. Device Description The LungPoint So… | 2010 |
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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 32 of the 76 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K112051.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The LungPoint®&ATV Planning and Navigation Software is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools and catheters in the pulmonary tract to a location in the tracheobronchial tree or lung tissue, and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not for pediatric use. When under fluoroscopy guidance, the software enables users to segment previously…
Read the full statement (135 words)
The LungPoint®&ATV Planning and Navigation Software is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools and catheters in the pulmonary tract to a location in the tracheobronchial tree or lung tissue, and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not for pediatric use.
When under fluoroscopy guidance, the software enables users to segment previously acquired 3D CT dlatasets and overlay and register these 3D segmented data sets with live fluoroseopy X-ray images of the same anatomy in order to support catheter/device navigatjon. The 3D segmented data set can be displayed with a color map annotation received from an external source.
The LungPoint tools (needle, balloon dilator, and sheath) arc used with a bronchoscope, navigated by the LungPoint Software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133385: Lungpoint Atv Planning and Navigation Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133385
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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