510(k) · Cleared
ClearedInreach System
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 Mar 31, 2008 as substantially equivalent to K071473 (Superdimension, Ltd., 2007) after a 59-day review. Its family tree reaches back 8 generations to 1993. 6 of the 69 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it.
- Decided
- Mar 31, 2008
- Review
- 59 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K926514 (1993). 16 ancestors in all, the oldest K882061 (1988). 52 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 · 8 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 7 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 6 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 5 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 4 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 3 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 2 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 1 generation backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- This deviceK080271 Inreach SystemSuperdimension, Ltd. · 2008
- Descendant · cites it directly · 45 of its ownK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- Descendant · 2 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · 3 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · 3 generations on · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- Descendant · 3 generations on · 11 of its ownK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…6 generations back · 2003
- K190106 Intra-Operative Positioning System; Simple Curve…5 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
Most influential descendants
Showing 5 of 52 · See all- K081379Modification to Inreach SystemSuperdimension, Ltd. · 2008 · cites it directly45descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 2 generations on30descendants
- K110256The IC-Pro SystemPaieon, Inc. · 2011 · 3 generations on15descendants
- K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · 3 generations on13descendants
- K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −7 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −6 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −5 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −4 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −3 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −2 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −1 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| 0 (this device) | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| +1 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| +2 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +3 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +3 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| +3 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
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 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K071473 | Modification to Superdimension/Bronchus Premium 2Summary page 1…phy x-ray system 21 CFR Part 892.1750 Product code JAK Equivalent Legally-Marketed Device: superDimension/Bronchus Premium 2, K071473 0013 Description: The superDimension/… | 2007 |
What descends from it? (52)
See all 523 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 · 6 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 · 5 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 · 6 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 · 6 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 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 6 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 15 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 8 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K081379 (Superdimension, Ltd., 2008) has gone furthest, with 45 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. 2008, 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/K080271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080271: Inreach System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080271
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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