# K963795: Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Dec 23, 1996 after 91 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921244 (1992). 7 ancestors in all.
158 later devices descend from it; 1 cites it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921690: Flexible Fiberoptic Sigmoidoscope System, Vision-Sciences, Inc. (1992) Summary page 2.
- K932843: Flexible Video Sigmoidoscope System W/Disp. Sheath, Vision-Sciences, Inc. (1994) Summary page 2.
- K961591: Disposable Endosheath for E-F100 Flexible Nasopharyngoscope, Vision-Sciences, Inc. (1996) Summary page 3.
- K950809: Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes, Vision-Sciences, Inc. (1996) Summary page 3.
- (no number) Model BF-3C20 Bronchoscope: named in the summary without a submission number
- (no number) Model FB-10X Bronchoscope, Model FB-18RX Bronchoscope and Model FI-10P Intubation Scope: named in the summary without a submission number

## Most influential descendants
- K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System (2002), 157 descendants of its own
- K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System (2003), 92 descendants of its own
- K072088: Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems (2007), 70 descendants of its own
- K091768: Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor & Accessories (2009), 66 descendants of its own
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview (2013), 64 descendants of its own

## Indications for use
The Vision Sciences (VSI) Bronchoscope and Disposable Sheath System will be used for diagnostic examination of the inside of the trachea or windpipe and other major air passages of the lungs. It may also be used to gather specimens and to find and remove foreign objects in the lungs.

Source page: https://510kreport.com/device/K963795
Methodology: https://510kreport.com/methodology