510(k) · Cleared
ClearedSuperdimension Marker Delivery Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Superdimension, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 11, 2011 as substantially equivalent to K071473 (Superdimension, Ltd., 2007) and 2 other predicates after a 30-day review. Its family tree reaches back 12 generations to 1993. 1 of the 25 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Feb 11, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K926514 (1993). 20 ancestors in all, the oldest K882061 (1988). 4 later devices descend from it, 1 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 8 generations between
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK092365 Inreach System, Model AAS00161-02Superdimension, Ltd. · 2009
- 1 generation backK102604 I-Logic Inreach SystemSuperdimension, Ltd. · 2010
- This deviceK110093 Superdimension Marker Delivery KitSuperdimension, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK112051 Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK133385 Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc. · 2014
Show all 12 generations
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 10 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 9 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 8 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 7 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 6 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 5 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 4 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK092365 Inreach System, Model AAS00161-02Superdimension, Ltd. · 2009
- 1 generation backK102604 I-Logic Inreach SystemSuperdimension, Ltd. · 2010
- This deviceK110093 Superdimension Marker Delivery KitSuperdimension, Inc. · 2011
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…6 generations back · 2003
Most influential descendants
Showing 4 of 4 · See all- K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc. · 2011 · cites it directly3descendants
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
- K200315Ziostation2Ziosoft, Inc. · 2020 · 3 generations on0descendants
- K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −11 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −10 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −9 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −8 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −7 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −6 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −5 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −4 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −3 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K092365 | Inreach System, Model AAS00161-02 | Superdimension, Ltd. | 2009 | — |
| −1 | K102604 | I-Logic Inreach System | Superdimension, Ltd. | 2010 | — |
| 0 (this device) | K110093 | Superdimension Marker Delivery Kit | Superdimension, Inc. | 2011 | — |
| +1 | K112051 | Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software | Broncus Technologies, Inc. | 2011 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +3 | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | — |
| +2 | K133385 | Lungpoint Atv Planning and Navigation Software | Broncus Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K071473 | Modification to Superdimension/Bronchus Premium 2Summary page 1…ation 21 CFR Part 892.1750 Product Code(s) JAK Legally marketed device(s) superDimension [-Logic inReach System, K071 473IK092365K1 02604 to which equivalence is claimed Reason for 51 0(k) Introduction of accessory Marker Delivery Ki… | 2007 |
| * | K092365 | Inreach System, Model AAS00161-02Summary page 1…21 CFR Part 892.1750 Product Code(s) JAK Legally marketed device(s) superDimension [-Logic inReach System, K071 473IK092365K1 02604 to which equivalence is claimed Reason for 51 0(k) Introduction of accessory Marker Delivery Kit for th… | 2009 |
| * | K102604 | I-Logic Inreach SystemSummary page 1…21 CFR Part 892.1750 Product Code(s) JAK Legally marketed device(s) superDimension [-Logic inReach System, K071 473IK092365K1 02604 to which equivalence is claimed Reason for 51 0(k) Introduction of accessory Marker Delivery Kit for the placem… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112051 | Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software | 2011 | 3 |
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 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 8 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K112051 (Broncus Technologies, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K071473.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110093 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110093: Superdimension Marker Delivery Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110093
Report an extraction error
Are you the manufacturer?
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