510(k) · Cleared
Recalled · Class II · 2023Airway Mobilescope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jan 26, 2021 as substantially equivalent to K082720 (Olympus Medical Systems Corporation, 2008) after a 256-day review. Its family tree reaches back 5 generations to 1993. 1 of the 11 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- Jan 26, 2021
- Review
- 256 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931154 (1993). 10 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- 2 generations backK033225 Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its…Olympus Optical Co., Ltd. · 2003 · Recalled
- 1 generation backK082720 Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005Olympus Medical Systems Corporation · 2008 · Recalled
- This deviceK201300 Airway MobilescopeOlympus Medical Systems Corp. · 2021
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…2 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| −2 | K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and… | Olympus Optical Co., Ltd. | 2003 | 5 |
| −1 | K082720 | Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005 | Olympus Medical Systems Corporation | 2008 | 3 |
| 0 (this device) | K201300 | Airway Mobilescope | Olympus Medical Systems Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 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.
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 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? (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 |
|---|---|---|---|
| * | K082720 | Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005Summary page 5…ce Device name 510(k) Submitter 510(k) No. TRACHEAL INTUBATION OLYMPUS MEDICAL K082720 FIBERVIDEOSCOPE SYSTEMS CORP. LF-Y0004 and LF-Y0005 ◼ Reference device As for the AIRWAY MOBILESCOP… | 2008 |
| † | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0340-2024 | 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-2499-2023 | 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations back · ◆ on the line of descent in FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 5.1 years on median.
- 7 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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?
This instrument has been designed to be used with a Suction Pump and other ancillary equipment for airway management, which includes diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
This instrument has been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201300: Airway Mobilescope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201300
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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