510(k) · Cleared
ClearedB-F200 Bronchoscope with BSS-F21 Endosheath System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on May 24, 2002 as substantially equivalent to K963795 (Vision-Sciences, Inc., 1996) and 1 other predicate after a 25-day review. Its family tree reaches back 3 generations to 1992. 157 later devices descend from it.
- Decided
- May 24, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921244 (1992). 9 ancestors in all. 157 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 2 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 1 generation backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- This deviceK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- Descendant · cites it directly · 92 of its ownK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- Descendant · 2 generations on · 70 of its ownK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
- Descendant · cites it directly · 66 of its ownK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009
- Descendant · 2 generations on · 64 of its ownK130845 Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013
- Descendant · 3 generations on · 40 of its ownK161656 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu…Ambu A/S · 2016
Showing 5 of 157 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 157 · See all- K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003 · cites it directly92descendants
- K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc. · 2007 · 2 generations on70descendants
- K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc. · 2009 · cites it directly66descendants
- K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013 · 2 generations on64descendants
- K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8…Ambu A/S · 2016 · 3 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −2 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −1 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| 0 (this device) | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| +1 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| +2 | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and… | Vision-Sciences, Inc. | 2007 | — |
| +1 | K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System… | Vision-Sciences, Inc. | 2009 | — |
| +2 | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | Ambu A/S | 2013 | — |
| +3 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 5 | 0 |
| 2016 | 8 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 EOQ? 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 |
|---|---|---|---|
| * | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathSummary page 1…rotective sheath system Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K963795 — Bronchoscope with Disposable EndoSheath® K990354 — Modified EndoSheath® for Flexible ENT Scopes Manufactured by: Vision-Scienc… | 1996 |
| * | K990354 | EndosheathSummary page 1…to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K963795 — Bronchoscope with Disposable EndoSheath® K990354 — Modified EndoSheath® for Flexible ENT Scopes Manufactured by: Vision-Sciences, Inc. 9 Strathmore Road Natick, MA 01760 Produc… | 1999 |
What descends from it? (157)
See all 1577 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | 2003 | 92 |
| K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050… | 2009 | 66 |
| K032688 | Colonosight Model 510B | 2004 | 38 |
| K024095 | Modification to Vision Sciences Endosheath System | 2003 | 31 |
| K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | 2004 | 26 |
| K061663 | Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for… | 2006 | 0 |
| K061324 | Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7 | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K031786 (Vision-Sciences, Inc., 2003) has gone furthest, with 92 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 VSI Flexible, Fiberoptic Bronchoscope with EndoSheath® System is used during flexible endoscopic examination of the trachea and other major passages of the lungs, to gather specimens, and/or to find and endoscopically remove foreign objects from the lungs. The EndoSheath® provides a sterile, disposable protective covering for the bronchoscope.
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/K021344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021344
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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