510(k) · Cleared
Recalled · 2006Superdimension/Bronchus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Superdimension, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 8, 2004 as substantially equivalent to K022354 (Ultraguide, Ltd., 2002) and 2 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1993. 6 of the 85 devices in its family, counting itself, have a Class I recall. 73 later devices descend from it. It has been recalled once.
- Decided
- Nov 8, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K926514 (1993). 11 ancestors in all, the oldest K882061 (1988). 73 later devices descend from it, 5 citing it directly. 6 of the 85 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 2 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 1 generation backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- This deviceK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004
- Descendant · cites it directly · 56 of its ownK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- Descendant · 2 generations on · 55 of its ownK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- Descendant · 3 generations on · 54 of its ownK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- Descendant · 4 generations on · 53 of its ownK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- Descendant · 5 generations on · 52 of its ownK080271 Inreach SystemSuperdimension, Ltd. · 2008
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…direct predicate · 2003
- K190106 Intra-Operative Positioning System; Simple Curve…10 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…11 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…11 generations on · 2024
Most influential descendants
Showing 5 of 73 · See all- K052260Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · cites it directly56descendants
- K052852Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · 2 generations on55descendants
- K062315Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · 3 generations on54descendants
- K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007 · 4 generations on53descendants
- K080271Inreach SystemSuperdimension, Ltd. · 2008 · 5 generations on52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −2 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −1 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| 0 (this device) | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | — |
| +1 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| +2 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| +3 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| +4 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| +5 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
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 |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 1 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 1 |
| 2024 | 4 | 2 |
| 2025 | 5 | 1 |
| 2026 | 3 | 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.
6 devices in this family have 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 |
|---|---|---|---|
| * | K022354 | Ultraguide CTG 2000SASummary page 1…Classification name: Bronchoscope (flexible or rigid) Regulation: 21 CRF 874.4680 3. Equivalent legally- marketed devices: Ultraguide CTG 2000sa K022354 Olympus UM-2R/3R K982323 7 Olympus BF IT 160 K023984 CCŽ% 4. De… | 2002 |
| * | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseSummary page 1…oscope (flexible or rigid) Regulation: 21 CRF 874.4680 3. Equivalent legally- marketed devices: Ultraguide CTG 2000sa K022354 Olympus UM-2R/3R K982323 7 Olympus BF IT 160 K023984 CCŽ% 4. Description SuperD… | 1998 |
| * | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesSummary page 1…. Equivalent legally- marketed devices: Ultraguide CTG 2000sa K022354 Olympus UM-2R/3R K982323 7 Olympus BF IT 160 K023984 CCŽ% 4. Description SuperDimension/Bronchus… | 2003 |
What descends from it? (73)
See all 735 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2006 | Not classified | Z-0666-2007 | Other | The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus… |
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 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 10 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 11 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 11 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 11 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K052260 (Superdimension, Ltd., 2005) has gone furthest, with 56 descendants of its own.
- 2 other devices also cite its predicate K022354.
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.
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 in the pulmonary tract. 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/K042438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042438: Superdimension/Bronchus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042438
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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