# K931154: Evis 200 System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Oct 7, 1993 after 213 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
No predicates in its family tree.
652 later devices descend from it; 10 cite it directly.
15 of 653 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Olympus EVS-Endoscopic Video Image and Data System (EVS): named in the summary without a submission number
- (no number) E-GIF Videoendoscope: named in the summary without a submission number
- (no number) E-JF Videoendoscope: named in the summary without a submission number
- (no number) E-CF Videoendoscope: named in the summary without a submission number
- (no number) EVS Video Processor: named in the summary without a submission number
- (no number) BF-N20 Bronchofiberscope: named in the summary without a submission number
- (no number) BF-B2 Bronchofiberscope: named in the summary without a submission number
- (no number) BF-5B Bronchofiberscope: named in the summary without a submission number
- (no number) BF-1T Bronchofiberscope: named in the summary without a submission number
- (no number) BF-4C2 Bronchofiberscope: named in the summary without a submission number
- (no number) BF-3C2 Bronchofiberscope: named in the summary without a submission number
- (no number) Disposable Biopsy Valve: named in the summary without a submission number
- (no number) Disposable Suction Valve: named in the summary without a submission number

## Most influential descendants
- K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories (1996), 573 descendants of its own
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment (1998), 431 descendants of its own
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series (2003), 350 descendants of its own
- K954451: Evis 140 System (1996), 318 descendants of its own
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA (2002), 268 descendants of its own

## Indications for use
The intended use of this system is for the endoscopic diagnosis and treatment in the airways including the tracheobronchial tree.

Source page: https://510kreport.com/device/K931154
Methodology: https://510kreport.com/methodology