# K021204: Olympus BF Type UM40

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: May 1, 2002 after 15 days
- Product code: PSV (Ultrasound Bronchoscope)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K853585 (1986). 14 ancestors in all.
44 later devices descend from it; 1 cites it directly.
1 of 59 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011886: Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160,, Olympus America, Inc. (2001) Summary page 4.
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 5.
- K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories, Olympus America, Inc. (1996) Summary page 7.
- K910423: Bronchoscope BF-N20, Olympus Corp. (1991) Summary page 7.

## Most influential descendants
- K042140: Olympus BF Type UC160-OL8 (2004), 43 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System (2007), 11 descendants of its own
- K093195: Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O (2010), 8 descendants of its own
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), 7 descendants of its own

## Indications for use
Intraluminal ultrasound for upper airways and tracheobronchial tree Intraluminal ultrasound for upper airways and tracheobronchial tree

Source page: https://510kreport.com/device/K021204
Methodology: https://510kreport.com/methodology