510(k) · Cleared
ClearedOlympus BF Type UM40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · PSV Ultrasound Bronchoscope
Cleared on May 1, 2002 as substantially equivalent to K011886 (Olympus America, Inc., 2001) and 3 other predicates after a 15-day review. Its family tree reaches back 4 generations to 1986. 1 of the 59 devices in its family, counting itself, has a Class I recall. 44 later devices descend from it.
- Decided
- May 1, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- PSV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K853585 (1986). 14 ancestors in all. 44 later devices descend from it, 1 citing it directly. 1 of the 59 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997 · Recalled
- 1 generation backK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
- This deviceK021204 Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002
- Descendant · cites it directly · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- Descendant · 2 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · 2 generations on · 11 of its ownK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- Descendant · 3 generations on · 8 of its ownK093195 Echotip Ultra Endobronchial High Definition Ultasound Needle, Model…Cook Ireland, Ltd. · 2010
- Descendant · 4 generations on · 7 of its ownK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX5 generations on · 2020
Most influential descendants
Showing 5 of 44 · See all- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · cites it directly43descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 2 generations on28descendants
- K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation · 2007 · 2 generations on11descendants
- K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd. · 2010 · 3 generations on8descendants
- K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd. · 2016 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | 2 |
| −1 | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | Olympus America, Inc. | 2001 | 1 |
| 0 (this device) | K021204 | Olympus BF Type UM40 | Olympus Optical Co., Ltd. | 2002 | — |
| +1 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| +2 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +2 | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka… | Olympus Medical Systems Corporation | 2007 | 3 |
| +3 | K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model… | Cook Ireland, Ltd. | 2010 | — |
| +4 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore… | Cook Ireland, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 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.
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 PSV device
- #1 K260401 Evis Eus Ultrasound Bronchofibervideoscope…score 14.6 · 10 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Summary page 4…Comments: Olympus EU-M60 EUS EXERA Endoscopic Ultrasound Center Previously cleared for use for Intraluminal ultrasound for upper airways and tracheobronchial tree under K011886 Spacification for "Other": Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for… | 2001 |
| * | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseSummary page 5…ronchial tree with transducer UM 2R/3R under K9882323 Specification for "Other": Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Cleared under K982323 (PLEASE 0O NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concumrence of CORH, Office of Device Evaluation (OD… | 1998 |
| * | K963033 | BF 240/P240/IT240 Bronchovideoscope & AccessoriesSummary page 7…K011886 TYPE UM160 Olympus UM-2R/ 3R Ultrasonic Probes and associated K982323 ancillary equipment (for bronchial use) BF-240/P240/1T7240 Bronchovideoscope & Accessories K963033 Bronchoscope BF-N20 K910423 D. Device Description 1. Summary This subject device has been designed to be used with an OLYMPUS… | 1996 |
| * | K910423 | Bronchoscope BF-N20Summary page 7…UM-2R/ 3R Ultrasonic Probes and associated K982323 ancillary equipment (for bronchial use) BF-240/P240/1T7240 Bronchovideoscope & Accessories K963033 Bronchoscope BF-N20 K910423 D. Device Description 1. Summary This subject device has been designed to be used with an OLYMPUS endoscopic ultrasound center… | 1991 |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042140 | Olympus BF Type UC160-OL8 | 2004 | 43 |
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.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 7 of the 14 ancestors have a recall of any class.
- Of its descendants, K042140 (Olympus Corporation, 2004) has gone furthest, with 43 descendants of its own.
- 2 other devices also cite its predicate K011886.
How does its category compare?
All PSV devicesPSV Ultrasound Bronchoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PSV
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PSV
Too few PSV 510(k)s in any year since 2007 to give a median.
Recalls per year · PSV
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSV
1,479in 2025
MAUDE reports naming product code PSV, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 37 |
| 2019 | 1 | — | 0 | 23 |
| 2020 | 0 | — | 0 | 149 |
| 2021 | 0 | — | 0 | 134 |
| 2022 | 0 | — | 0 | 367 |
| 2023 | 0 | — | 1 | 717 |
| 2024 | 0 | — | 0 | 627 |
| 2025 | 0 | — | 0 | 1,479 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Intraluminal ultrasound for upper airways and
tracheobronchial tree
Intraluminal ultrasound for upper airways and
tracheobronchial tree
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021204 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021204: Olympus BF Type UM40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021204
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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