510(k) · Cleared
ClearedEvis 200 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Oct 7, 1993 after a 213-day review. The FDA summary names its predicate without a number. 15 of the 653 devices in its family, counting itself, have a Class I recall. 652 later devices descend from it.
- Decided
- Oct 7, 1993
- Review
- 213 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 0
652 later devices descend from it, 10 citing it directly. 15 of the 653 devices in this family, counting this one, have a Class I recall.
- This deviceK931154 Evis 200 SystemOlympus Corp. · 1993
- Descendant · cites it directly · 573 of its ownK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- Descendant · cites it directly · 431 of its ownK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- Descendant · 2 generations on · 350 of its ownK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- Descendant · cites it directly · 318 of its ownK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- Descendant · cites it directly · 268 of its ownK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
Showing 5 of 652 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 652 · See all- K963033BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · cites it directly573descendants
- K981543Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…The Olympus Optical Co. · 1998 · cites it directly431descendants
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations on350descendants
- K954451Evis 140 SystemOlympus America, Inc. · 1996 · cites it directly318descendants
- K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002 · cites it directly268descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| +1 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| +1 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| +2 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| +1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| +1 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 9 | 1 |
| 2004 | 7 | 0 |
| 2005 | 13 | 1 |
| 2006 | 7 | 2 |
| 2007 | 7 | 0 |
| 2008 | 13 | 0 |
| 2009 | 21 | 0 |
| 2010 | 12 | 0 |
| 2011 | 8 | 0 |
| 2012 | 22 | 0 |
| 2013 | 14 | 1 |
| 2014 | 23 | 0 |
| 2015 | 21 | 0 |
| 2016 | 18 | 0 |
| 2017 | 14 | 0 |
| 2018 | 30 | 0 |
| 2019 | 46 | 2 |
| 2020 | 40 | 1 |
| 2021 | 38 | 1 |
| 2022 | 41 | 0 |
| 2023 | 50 | 1 |
| 2024 | 57 | 3 |
| 2025 | 75 | 2 |
| 2026 | 48 | 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.
15 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? (13)
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 |
|---|---|---|---|
| * | — | Olympus EVS-Endoscopic Video Image and Data System (EVS) Named without a submission number | |
| * | — | E-GIF Videoendoscope Named without a submission number | |
| * | — | E-JF Videoendoscope Named without a submission number | |
| * | — | E-CF Videoendoscope Named without a submission number | |
| * | — | EVS Video Processor Named without a submission number | |
| * | — | BF-N20 Bronchofiberscope Named without a submission number | |
| * | — | BF-B2 Bronchofiberscope Named without a submission number | |
| * | — | BF-5B Bronchofiberscope Named without a submission number | |
| * | — | BF-1T Bronchofiberscope Named without a submission number | |
| * | — | BF-4C2 Bronchofiberscope Named without a submission number | |
| * | — | BF-3C2 Bronchofiberscope Named without a submission number | |
| * | — | Disposable Biopsy Valve Named without a submission number | |
| * | — | Disposable Suction Valve Named without a submission number |
What descends from it? (652)
See all 65210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | 1996 | 573 |
| K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary… | 1998 | 431 |
| K954451 | Evis 140 System | 1996 | 318 |
| K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | 2002 | 268 |
| K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary… | 2003 | 60 |
| K060243 | Olympus Guide Sheath, Model XBO1-836-13 Class I | 2006 | 11 |
| K031256 | Xsif-1TQ140A Small Intestinal Videoscope | 2003 | 5 |
| K022446 | Mucus Collection Probe, Models BC-401C & BC-402C | 2003 | 0 |
| K012073 | Olympus Spray Catheter PW-6C-1 | 2001 | 0 |
| K962380 | Olympus BF Type 200 Video Bronchscopes (BF-200/BF-P200/BF-IT200) | 1996 | 0 |
Has anything in its family been recalled? (15 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.
- K060243Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 114 Class I recalls
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · 3 generations on · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 13 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 · 14 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
Nearest 12 of 15 shown.
Nearest 5 of 15; all are on the web page.
What does this lineage say?
- Of its descendants, K963033 (Olympus America, Inc., 1996) has gone furthest, with 573 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.
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?
The intended use of this system is for the endoscopic diagnosis and treatment in the airways including the 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/K931154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931154: Evis 200 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931154
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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