510(k) · Cleared
Recalled · Class II · 2020Rhino-Laryngo Fiberscope Olympus ENF-GP2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Oct 4, 2018 as substantially equivalent to K013591 (Olympus Optical Co., Ltd., 2001) after a 147-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 4, 2018
- Review
- 147 days
- Class
- Class II
- Product code
- EOB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931154 (1993). 9 ancestors in all, the oldest K850978 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 3 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 2 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 1 generation backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- This deviceK181240 Rhino-Laryngo Fiberscope Olympus ENF-GP2Olympus Medical Systems Corp. · 2018
- Descendant · cites it directly · 0 of its ownK221660 Rhino-Laryngofiberscope Olympus Enf Type-XPOlympus Medical Systems Corp. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K221660Rhino-Laryngofiberscope Olympus Enf Type-XPOlympus Medical Systems Corp. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −3 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −2 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −1 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| 0 (this device) | K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 | Olympus Medical Systems Corp. | 2018 | — |
| +1 | K221660 | Rhino-Laryngofiberscope Olympus Enf Type-XP | Olympus Medical Systems Corp. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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.
Planning a device in EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 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 |
|---|---|---|---|
| * | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentSummary page 5…ancillary equipment ■ Common Name: Fiber Scope for Rhino-Laryngo ■ Applicant OLYMPUS MEDICAL SYSTEMS CORP. ■ 510(k) No. K013591 510(k) Summary Page 2 of 8… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221660 | Rhino-Laryngofiberscope Olympus Enf Type-XP | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2020 | Class II | Z-2292-2020 | Under Investigation by firm | Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K221660 (Olympus Medical Systems Corp., 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K013591.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181240: Rhino-Laryngo Fiberscope Olympus ENF-GP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181240
Report an extraction error
Are you the manufacturer?
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