510(k) · Cleared
ClearedModification to Superdimension/Bronchus Premium 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Superdimension, Ltd. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jul 12, 2007 as substantially equivalent to K062315 (Superdimension, Ltd., 2006) after a 44-day review. Its family tree reaches back 7 generations to 1993. 6 of the 69 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it.
- Decided
- Jul 12, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K926514 (1993). 15 ancestors in all, the oldest K882061 (1988). 53 later devices descend from it, 3 citing it directly. 6 of the 69 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 6 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 5 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 4 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 3 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 2 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 1 generation backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- This deviceK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- Descendant · cites it directly · 52 of its ownK080271 Inreach SystemSuperdimension, Ltd. · 2008
- Descendant · 2 generations on · 45 of its ownK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- Descendant · 3 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · 4 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · 4 generations on · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…5 generations back · 2003
- K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
Most influential descendants
Showing 5 of 53 · See all- K080271Inreach SystemSuperdimension, Ltd. · 2008 · cites it directly52descendants
- K081379Modification to Inreach SystemSuperdimension, Ltd. · 2008 · 2 generations on45descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 3 generations on30descendants
- K110256The IC-Pro SystemPaieon, Inc. · 2011 · 4 generations on15descendants
- K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −6 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −5 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −4 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −3 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −2 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −1 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| 0 (this device) | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| +1 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| +2 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| +3 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +4 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +4 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 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 |
|---|---|---|---|
| * | K062315 | Superdimension/Bronchus Premium 2Summary page 1…aphy x-ray system 21 CFR 892.1750 Product code JAK Equivalent Legally-Marketed Device: superDimensionlBronchus Premium 2, K0623 15 no00(go0 Description: The superDimen… | 2006 |
What descends from it? (53)
See all 533 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)
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
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 6 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 · 7 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 · 7 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 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 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 14 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 8 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K080271 (Superdimension, Ltd., 2008) has gone furthest, with 52 descendants of its own.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
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/K071473 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071473: Modification to Superdimension/Bronchus Premium 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071473
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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