510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Olympus Hyf-P Flexible Hysterofiberscope

K891451510(k) TraditionalCleared Oct 2, 1989201-day reviewClass II21 CFR 884.1690Recalls 1

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

Olympus Corp. · HIH Hysteroscope (And Accessories)

Cleared on Oct 2, 1989 after a 201-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it. It has been recalled once.

Decided
Oct 2, 1989
Review
201 days
Class
Class II
Product code
HIH
Recalls
1
Predicates
0

31 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2022: 1 descendant cleared2026: 3 descendants cleared2018: 2 descendants cleared2010: 1 descendant cleared2013: 1 descendant cleared2019: 7 descendants cleared2017: 1 descendant cleared2014: 1 descendant cleared2020: 2 descendants cleared2021: 3 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK891451 Olympus Hyf-P Flexible HysterofiberscopeOlympus Corp. · 1989
  2. Descendant · cites it directly · 24 of its ownK022445 Visera Hysterovideoscope Olympus Hyf Type VOlympus Optical Co., Ltd. · 2003 · Recalled
  3. Descendant · 2 generations on · 22 of its ownK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
  4. Descendant · 3 generations on · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
  5. Descendant · 4 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
  6. Descendant · 4 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12009: 12010: 12013: 12014: 12015: 12016: 12017: 12018: 22019: 72020: 22021: 32022: 12024: 32025: 12026: 3
2003high 7 (2019) · low 0 (2004)2026

Most influential descendants

Showing 5 of 31 · See all
  • K022445Visera Hysterovideoscope Olympus Hyf Type VOlympus Optical Co., Ltd. · 2003 · cites it directly24descendants
  • K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009 · 2 generations on22descendants
  • K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · 3 generations on20descendants
  • K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 4 generations on19descendants
  • K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891451Olympus Hyf-P Flexible HysterofiberscopeOlympus Corp.1989—
+1K022445Visera Hysterovideoscope Olympus Hyf Type VOlympus Optical Co., Ltd.20031
+2K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.2009—
+3K123151Endosee Model 8000 U-ScopeEndosee Corp2013—
+4K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation2014—
+4K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
200910
201010
201310
201410
201510
201610
201710
201820
201970
202020
202130
202210
202430
202510
202630
FIG. 1 — Lineage of K891451, 1989–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HIH? 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 HIH device

  1. #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K022445Visera Hysterovideoscope Olympus Hyf Type VOlympus Optical Co., Ltd.200324
K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 25, 2023Class IIZ-0335-2024Under Investigation by firmChannel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K022445 (Olympus Optical Co., Ltd., 2003) has gone furthest, with 24 descendants of its own.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIH

3in 2025

2007: 12008: 22009: 42010: 42011: 32012: 42013: 52014: 22015: 52016: 32017: 22018: 82019: 142020: 72021: 42022: 22023: 42024: 62025: 32026 (partial year): 7
2007high 14 (2019) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIH

111in 2025

2009: 130 days median2010: 109 days median2011: 118 days median2012: 25 days median2013: 144 days median2015: 52 days median2016: 106 days median2018: 135 days median2019: 91 days median2020: 88 days median2021: 194 days median2023: 200 days median2024: 148 days median2025: 111 days median2026 (partial year): 168 days median
2007high 200 (2023) · low 25 (2012)2026

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

Recalls per year · HIH

3so far in 2026, the most since 2007

2019: 12023: 22026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · HIH

1,698in 2025

2007: 72008: 122009: 172010: 312011: 592012: 782013: 1112014: 1252015: 2112016: 1722017: 3362018: 1822019: 2202020: 2532021: 1932022: 2892023: 1,4492024: 1,6112025: 1,698
2007high 1,698 (2025) · low 7 (2007)2025

MAUDE reports naming product code HIH, 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
20071—07
20082—012
20094130017
20104109031
20113118059
2012425078
201351440111
20142—0125
20155520211
201631060172
20172—0336
201881350182
201914911220
20207880253
202141940193
20222—0289
2023420021,449
2024614801,611
2025311101,698
202671683—

More from Olympus Corp.

142 FDA decisions under this applicant name. See the company

  • K915402EW-10 and EW-20Olympus Corp. · 1995
  • K933200Olympus PBD StentsOlympus Corp. · 19954 recalls
  • K942338Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesOlympus Corp. · 1994
  • K931763HF-Resection Electrode, Loop W/Runner Endos/AccessOlympus Corp. · 1994
  • K934835FlovalOlympus Corp. · 1994

Recent decisions in HIH

The HIH category page

  • K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver…Karl Storz SE & CO. KG · 2026
  • K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd. · 2026
  • K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc. · 2026
  • K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc. · 2026

https://510kreport.com/device/K891451 · printed Nov 6, 2026

Cite this page

510(k) Report. “K891451: Olympus Hyf-P Flexible Hysterofiberscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891451

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026