# K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jun 15, 2017 after 258 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K993704 (2000). 7 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.

## Most influential descendants
- K193123: FUJIFILM Distal Cap Models 33-40 (2019), 2 descendants of its own
- K232314: Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) (2023), 1 descendant of its own
- K253568: Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (2026), 0 descendants of its own
- K252457: Disposable Distal End Tape Hood (2026), 0 descendants of its own
- K242635: Endoscopic Distal Attachment (AF-D series) (2025), 0 descendants of its own

## Indications for use
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

Source page: https://510kreport.com/device/K162749
Methodology: https://510kreport.com/methodology