510(k) · Cleared
Recalled · Class II · 2023Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jun 8, 1998 as substantially equivalent to K850978 (Olympus Corp., 1985) and 4 other predicates after a 39-day review. Its family tree reaches back 2 generations to 1993. 6 of the 437 devices in its family, counting itself, have a Class I recall. 431 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 8, 1998
- Review
- 39 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 5
- Predicates
- 5
Its longest line of descent runs back 2 generations to K931154 (1993). 5 ancestors in all, the oldest K850978 (1985). 431 later devices descend from it, 7 citing it directly. 6 of the 437 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 1 generation backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- This deviceK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998
- Descendant · cites it directly · 268 of its ownK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- Descendant · cites it directly · 176 of its ownK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- Descendant · 2 generations on · 160 of its ownK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- Descendant · 2 generations on · 159 of its ownK052452 Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005
- Descendant · 3 generations on · 159 of its ownK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
Showing 5 of 431 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 431 · See all- K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002 · cites it directly268descendants
- K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd. · 2001 · cites it directly176descendants
- K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002 · 2 generations on160descendants
- K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005 · 2 generations on159descendants
- K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003 · 3 generations on159descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −1 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| 0 (this device) | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | — |
| +1 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| +1 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| +2 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| +2 | K052452 | Visera Rhino-Laryngovideoscope Olympus Enf Type VT | Olympus Medical Systems Corporation | 2005 | — |
| +3 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 1 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 1 |
| 2014 | 10 | 0 |
| 2015 | 12 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 19 | 0 |
| 2019 | 31 | 1 |
| 2020 | 31 | 0 |
| 2021 | 32 | 1 |
| 2022 | 36 | 0 |
| 2023 | 42 | 0 |
| 2024 | 51 | 1 |
| 2025 | 61 | 1 |
| 2026 | 35 | 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? (5)
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 |
|---|---|---|---|
| * | K850978 | Olympus LF-1 Intubation ScopeSummary page 1…lassification: Bronchoscope and accessories Class II, 21 CFR 874.4680 D. Legally Marketed Devices which we Claim Substantial Equivalence Olympus LF-1 Intubation Scope K850978 Olympus BF-240 Bronchovideoscope K963033 Olympus BF-200 Bronchovideoscope K931154 Olympus BF-P200 Bronchovideoscope K931154 Olymp… | 1985 |
| * | K963033 | BF 240/P240/IT240 Bronchovideoscope & AccessoriesSummary page 1…es Class II, 21 CFR 874.4680 D. Legally Marketed Devices which we Claim Substantial Equivalence Olympus LF-1 Intubation Scope K850978 Olympus BF-240 Bronchovideoscope K963033 Olympus BF-200 Bronchovideoscope K931154 Olympus BF-P200 Bronchovideoscope K931154 Olympus Winter & Ibe A5255A Rigid Endoscope K9… | 1996 |
| * | K931154 | Evis 200 SystemSummary page 1…Marketed Devices which we Claim Substantial Equivalence Olympus LF-1 Intubation Scope K850978 Olympus BF-240 Bronchovideoscope K963033 Olympus BF-200 Bronchovideoscope K931154 Olympus BF-P200 Bronchovideoscope K931154 Olympus Winter & Ibe A5255A Rigid Endoscope K923982 Olympus A3093 Light Guide Cable, 3… | 1993 |
| * | K923982 | Olympus Oes Laparoscopy SystemSummary page 1…8 Olympus BF-240 Bronchovideoscope K963033 Olympus BF-200 Bronchovideoscope K931154 Olympus BF-P200 Bronchovideoscope K931154 Olympus Winter & Ibe A5255A Rigid Endoscope K923982 Olympus A3093 Light Guide Cable, 3.5 mm plug type K944072 E. Description of the Device The Olympus LF-TP and LF… | 1993 |
| * | K944072 | Olympus Nasal and Sinus EndoscopesSummary page 1…ronchovideoscope K931154 Olympus BF-P200 Bronchovideoscope K931154 Olympus Winter & Ibe A5255A Rigid Endoscope K923982 Olympus A3093 Light Guide Cable, 3.5 mm plug type K944072 E. Description of the Device The Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes and it’s accessories ar… | 1995 |
What descends from it? (431)
See all 4317 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | 2002 | 268 |
| K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | 2001 | 176 |
| K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary Equipment | 2001 | 83 |
| K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | 2001 | 82 |
| K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | 2013 | 64 |
| K082720 | Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005 | 2008 | 1 |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope… | 2022 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2023 | Class II | Z-0557-2024 | Under Investigation by firm | Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification. |
| Sep 25, 2023 | Class II | Z-0332-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Sep 25, 2023 | Class II | Z-0338-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Sep 25, 2023 | Class II | Z-0344-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Jul 27, 2023 | Class II | Z-2504-2023 | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 16 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
- 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
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K021074 (Olympus America, Inc., 2002) has gone furthest, with 268 descendants of its own.
- 1 other device also cites its predicate K850978.
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?
Olympus LF-TP and LF-DP Tracheal Intubation Fiberscope, accessories and ancillary equipment are intended for airway management which includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation, and management.
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/K981543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981543
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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