510(k) Report

510(k) · Cleared

Cleared

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

K162749510(k) TraditionalCleared Jun 15, 2017258-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujifilm Medical Systems U.S.A, Inc. · FDS Gastroscope And Accessories, Flexible/Rigid

Cleared on Jun 15, 2017 as substantially equivalent to K143556 (Fujifilm Medical Systems U.S.A, Inc., 2015) after a 258-day review. Its family tree reaches back 4 generations to 2000. 8 later devices descend from it.

Decided
Jun 15, 2017
Review
258 days
Class
Class II
Product code
FDS
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K993704 (2000). 7 ancestors in all, the oldest K944759 (1995). 8 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1995: 2 other ancestors2023: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2026: 2 descendants cleared2025: 1 descendant cleared2024: 1 descendant clearedK993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 2000K040048 · Fujinon Double Balloon Enteroscopy System · Fujinon, Inc. · 2004K090116 · Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 · Fujinon, Inc. · 2009K143556 · Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T · Fujifilm Medical Systems U.S.A, Inc. · 20151995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 3 descendants K143556 · Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T · Fujifilm Medical Systems U.S.A, Inc. · 2015K090116 · Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 · Fujinon, Inc. · 2009K040048 · Fujinon Double Balloon Enteroscopy System · Fujinon, Inc. · 2004K993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 20000
  1. Root · 4 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
  2. 3 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
  3. 2 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
  4. 1 generation backK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
  5. This deviceK162749 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017
  6. Descendant · cites it directly · 2 of its ownK193123 FUJIFILM Distal Cap Models 33-40Fujifilm Corporation · 2019
  7. Descendant · cites it directly · 1 of its ownK232314 Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation · 2023
  8. Descendant · 2 generations on · 0 of its ownK253568 Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood…Fujifilm Corporation · 2026
  9. Descendant · cites it directly · 0 of its ownK252457 Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd. · 2026
  10. Descendant · cites it directly · 0 of its ownK242635 Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019: 12021: 22023: 12024: 12025: 12026: 2
2019high 2 (2021) · low 0 (2020)2026

Most influential descendants

Showing 5 of 8 · See all
  • K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation · 2019 · cites it directly2descendants
  • K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation · 2023 · cites it directly1descendant
  • K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…Fujifilm Corporation · 2026 · 2 generations on0descendants
  • K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd. · 2026 · cites it directly0descendants
  • K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K993704Gastro-Intestinal System EN-410WMFujinon, Inc.2000—
−3K040048Fujinon Double Balloon Enteroscopy SystemFujinon, Inc.2004—
−2K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc.2009—
−1K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.2015—
0 (this device)K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.2017—
+1K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation2019—
+1K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation2023—
+2K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood…Fujifilm Corporation2026—
+1K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.2026—
+1K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202120
202310
202410
202510
202620
FIG. 1 — Lineage of K162749, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FDS? 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 FDS device

  1. #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
Summary page 4
…ories (Flexible/Rigid) 21 CFR FDF 876.1500 Predicate Devices x Fujifilm Hood Model DH-17EN (K143556) 023…
Fujifilm Medical Systems U.S.A, Inc.2015—

Also cleared against K143556: 6 other devices →

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation20192
K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation20231
K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.20260
K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.20250
K210915Pathfinder Endoscope CapNeptune Medical, Inc.20210

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 17 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • Of its descendants, K193123 (Fujifilm Corporation, 2019) has gone furthest, with 2 descendants of its own.
  • 6 other devices also cite its predicate K143556.

How does its category compare?

All FDS devices

FDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · FDS

8in 2025

2007: 22010: 12011: 12012: 32013: 22014: 22015: 22016: 12017: 12018: 62019: 52020: 22021: 52022: 22023: 32024: 52025: 82026 (partial year): 7
2007high 8 (2025) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDS

211in 2025

2012: 181 days median2018: 167 days median2019: 175 days median2021: 78 days median2023: 133 days median2024: 220 days median2025: 211 days median2026 (partial year): 164 days median
2007high 220 (2024) · low 78 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FDS

2in 2024

2013: 12016: 12020: 22024: 2
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FDS

18,905in 2025

2007: 272008: 112009: 212010: 452011: 362012: 352013: 82014: 232015: 292016: 1082017: 1782018: 3042019: 1,3762020: 6012021: 1,7552022: 6,2162023: 9,8742024: 9,2582025: 18,905
2007high 18,905 (2025) · low 8 (2013)2025

MAUDE reports naming product code FDS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—027
20080—011
20090—021
20101—045
20111—036
20123181035
20132—18
20142—023
20152—029
20161—1108
20171—0178
201861670304
2019517501,376
20202—2601
202157801,755
20222—06,216
2023313309,874
2024522029,258
20258211018,905
202671640—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K143556

6 other devices cite the same predicate.

  • K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024
  • K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton · 2023
  • K213195Balloon BS-3Fujifilm Corporation · 2021
  • K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation · 2019
  • K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation · 2019
  • K153483Balloon controller PB-30Fujifilm Medical Systems U.S.A, Inc. · 2015

More from Fujifilm Medical Systems U.S.A, Inc.

44 FDA decisions under this applicant name. See the company

  • P160031/S004ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) OptionFujifilm Medical Systems U.S.A, Inc. · 2023
  • P160031/S003ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) OptionFujifilm Medical Systems U.S.A, Inc. · 2020
  • P160031/S002Aspire Cristalle Digital Breast Tomosynthesis OptionFujifilm Medical Systems U.S.A, Inc. · 2019
  • P160031/S001ASPIRE Cristalle Breast Tomosynthesis SystemFujifilm Medical Systems U.S.A, Inc. · 2019
  • K171291FUJIFILM Bronchoscope Model EB-530PFujifilm Medical Systems U.S.A, Inc. · 2018

Recent decisions in FDS

The FDS category page

  • K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
  • K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026
  • K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2026

https://510kreport.com/device/K162749 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162749

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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