510(k) · Cleared
ClearedVideo Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hunan Vathin Medical Instrument Co., Ltd. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Oct 29, 2024 as substantially equivalent to K210883 (Ambu A/S, 2021) and 1 other predicate after a 146-day review. Its family tree reaches back 12 generations to 1992. 2 of the 43 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 29, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K921244 (1992). 42 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet. 2 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 8 generations between
- 3 generations backK173727 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2…Ambu A/S · 2018
- 2 generations backK220606 Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2…Ambu A/S · 2022
- 1 generation backK223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD…Ambu A/S · 2023 · Recalled
- This deviceK241612 Video Bronchoscope System; Single-use Flexible Bronchoscope…Hunan Vathin Medical Instrument Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 11 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 10 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 9 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 8 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 7 generations backK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
- 6 generations backK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009
- 5 generations backK130845 Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013
- 4 generations backK161656 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu…Ambu A/S · 2016
- 3 generations backK173727 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2…Ambu A/S · 2018
- 2 generations backK220606 Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2…Ambu A/S · 2022
- 1 generation backK223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD…Ambu A/S · 2023 · Recalled
- This deviceK241612 Video Bronchoscope System; Single-use Flexible Bronchoscope…Hunan Vathin Medical Instrument Co., Ltd. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −11 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −10 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −9 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −8 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −7 | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and… | Vision-Sciences, Inc. | 2007 | — |
| −6 | K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System… | Vision-Sciences, Inc. | 2009 | — |
| −5 | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | Ambu A/S | 2013 | — |
| −4 | K161656 | Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large… | Ambu A/S | 2016 | — |
| −3 | K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope… | Ambu A/S | 2018 | — |
| −2 | K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | Ambu A/S | 2022 | — |
| −1 | K223299 | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®… | Ambu A/S | 2023 | 1 |
| 0 (this device) | K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L… | Hunan Vathin Medical Instrument Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 1 |
| 2011 | 1 | 0 |
| 2021 | 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.
2 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? (2)
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 |
|---|---|---|---|
| * | K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8Summary page 6…Page 6 === Premarket Notification 510(k) Submission III Predicate Device 510 (k) Number K210883 K223299 aScope 4 Broncho Regular Sampler Set 5.0/2.2… | 2021 |
| * | K223299 | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Summary page 6…Premarket Notification 510(k) Submission III Predicate Device 510 (k) Number K210883 K223299 aScope 4 Broncho Regular Sampler Set 5.0/2.2… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 13 of the 42 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K210883.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Video Bronchoscope System is for use in professional Healthcare Facility Environment.
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/K241612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241612: Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241612
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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