510(k) Report

510(k) · Cleared

Cleared

Olympus FB Series Biopsy Forceps

K955065510(k) TraditionalCleared Jan 24, 199679-day reviewClass I21 CFR 876.1075

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

Olympus America, Inc. · FCL Forceps, Biopsy, Non-Electric

Cleared on Jan 24, 1996 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Jan 24, 1996
Review
79 days
Class
Class I
Product code
FCL
Recalls
None
Predicates
0

12 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1996: 1 descendant cleared2005: 1 descendant cleared2002: 1 descendant cleared2018: 1 descendant cleared2023: 2 descendants cleared2020: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955065 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
  2. Descendant · cites it directly · 9 of its ownK962555 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
  3. Descendant · 2 generations on · 7 of its ownK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
  4. Descendant · 3 generations on · 5 of its ownK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
  5. Descendant · 4 generations on · 2 of its ownK211493 Monarch PlatformAuris Health, Inc. · 2021 · Recalled
  6. Descendant · 5 generations on · 1 of its ownK243219 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1996: 12001: 12002: 12005: 12018: 12020: 12021: 22023: 22025: 12026: 1
1996high 2 (2021) · low 0 (1997)2026

Most influential descendants

Showing 5 of 12 · See all
  • K962555Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996 · cites it directly9descendants
  • K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · 2 generations on7descendants
  • K193534Monarch PlatformAuris Health, Inc. · 2020 · 3 generations on5descendants
  • K211493Monarch PlatformAuris Health, Inc. · 2021 · 4 generations on2descendants
  • K243219MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955065Olympus FB Series Biopsy ForcepsOlympus America, Inc.1996—
+1K962555Olympus FB Series Biopsy ForcepsOlympus America, Inc.1996—
+2K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.20181
+3K193534Monarch PlatformAuris Health, Inc.20204
+4K211493Monarch PlatformAuris Health, Inc.20212
+5K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.20251

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200110
200210
200510
201810
202010
202120
202320
202510
202610
FIG. 1 — Lineage of K955065, 1996–2026Source: 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 FCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K962555Olympus FB Series Biopsy ForcepsOlympus America, Inc.19969
K042659Medisiss Reprocessed Non-Electric GI Biopsy ForcepsMedisiss20050
K012074XBO1-824-18/19/20 Biopsy ForcepsThe Olympus Optical Co.20010

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?

  • Of its descendants, K962555 (Olympus America, Inc., 1996) has gone furthest, with 9 descendants of its own.

How does its category compare?

All FCL devices

FCL Forceps, Biopsy, Non-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCL

FDA has decided no FCL device since 2007.

Median 510(k) review, days · FCL

Too few FCL 510(k)s in any year since 2007 to give a median.

Recalls per year · FCL

3in 2010

2010: 32026 (partial year): 3
2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · FCL

55in 2025

2007: 582008: 1532009: 4102010: 4952011: 3772012: 972013: 582014: 862015: 512016: 642017: 2752018: 692019: 692020: 532021: 302022: 702023: 682024: 602025: 55
2007high 495 (2010) · low 30 (2021)2025

MAUDE reports naming product code FCL, 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
20070—058
20080—0153
20090—0410
20100—3495
20110—0377
20120—097
20130—058
20140—086
20150—051
20160—064
20170—0275
20180—069
20190—069
20200—053
20210—030
20220—070
20230—068
20240—060
20250—055
20260—3—

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

Recent decisions in FCL

The FCL category page

  • K032092Olympus Xcyf-TP3 Cystofiberscope/NephrofiberscopeOlympus Optical Co., Ltd. · 2003
  • K973611Spectrascience Reusable Biopsy ForcepsSpectrascience, Inc. · 1997
  • K971315Auxiliary Instruments for UrsRichard Wolf Medical Instruments Corp. · 19972 recalls
  • K964120Injecto FlushRobert J. Jynch, Jr. · 1996
  • K963517Spectra Science Biopsy ForcepsSpectrascience, Inc. · 1996

https://510kreport.com/device/K955065 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955065: Olympus FB Series Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955065

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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