510(k) · Cleared

Cleared

Olympus LF-1 Intubation Scope

K850978510(k) TraditionalCleared May 23, 198576-day reviewClass I21 CFR 868.5530

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

Olympus Corp. · CAL Laryngoscope, Non-Rigid

Cleared on May 23, 1985 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 434 devices in its family, counting itself, have a Class I recall. 433 later devices descend from it.

Decided: May 23, 1985
Review: 76 days
Class: Class I
Product code: CAL
Recalls: None
Predicates: 0

433 later devices descend from it, 2 citing it directly. 6 of the 434 devices in this family, counting this one, have a Class I recall.

This deviceK850978 Olympus LF-1 Intubation ScopeOlympus Corp. · 1985
Descendant · cites it directly · 431 of its ownK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
Descendant · 2 generations on · 268 of its ownK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
Descendant · 2 generations on · 176 of its ownK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
Descendant · 3 generations on · 160 of its ownK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
Descendant · 3 generations on · 159 of its ownK052452 Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005

Showing 5 of 433 descendants. See all descendants

Descendants cleared per year

1998high 61 (2025) · low 0 (1999)2026

Class I recalls in this family

K061313 Evis Exera 180 System4 generations on · 2006
K121959 Evis Exera Iii Video System4 generations on · 2013
K183419 EVIS EXERA III Bronchovideoscope Olympus BF-XT1906 generations on · 2019
K250862 Evis Exera Iii Bronchovideoscope (Olympus…6 generations on · 2025

Most influential descendants

Showing 5 of 433 · See all

K981543Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…The Olympus Optical Co. · 1998 · cites it directly431descendants
K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002 · 2 generations on268descendants
K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd. · 2001 · 2 generations on176descendants
K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002 · 3 generations on160descendants
K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005 · 3 generations on159descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K850978	Olympus LF-1 Intubation Scope	Olympus Corp.	1985	—
+1	K981543	Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and…	The Olympus Optical Co.	1998	5
+2	K021074	Visera Cystovideoscope Olympus Cyf Type V/VA	Olympus America, Inc.	2002	—
+2	K013591	Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment	Olympus Optical Co., Ltd.	2001	—
+3	K021073	Visera Rhinlaryngovideoscope Olympus Enf Type V	Olympus America, Inc.	2002	—
+3	K052452	Visera Rhino-Laryngovideoscope Olympus Enf Type VT	Olympus Medical Systems Corporation	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	3	0
2002	2	0
2003	3	0
2004	3	0
2005	3	0
2006	4	1
2007	2	0
2008	6	0
2009	4	0
2010	6	0
2011	1	0
2012	9	0
2013	9	1
2014	10	0
2015	12	0
2016	8	0
2017	9	0
2018	19	0
2019	31	1
2020	31	0
2021	32	1
2022	36	0
2023	42	0
2024	51	1
2025	61	1
2026	35	0

FIG. 1 — Lineage of K850978, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

6 devices in this family have a Class I recall. 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

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? (433)

See all 433

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

Number	Device	Applicant	Decided	Descendants
K981543	Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…	The Olympus Optical Co.	1998	431
K093186	Ambu Ascope and Monitor	Ambu A/S	2010	0

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 4 generations on · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

Of its descendants, K981543 (The Olympus Optical Co., 1998) has gone furthest, with 431 descendants of its own.

How does its category compare?

All CAL devices

CAL Laryngoscope, Non-Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAL

FDA has decided no CAL device since 2007.

Median 510(k) review, days · CAL

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

Recalls per year · CAL

1in 2021

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · CAL

86in 2025

2007high 268 (2023) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	3
2009	—	0	1
2010	—	0	49
2011	—	0	9
2012	—	0	10
2013	—	1	21
2014	—	0	21
2015	—	0	4
2016	—	0	7
2017	—	0	10
2018	—	0	4
2019	—	0	1
2020	—	0	2
2021	—	1	60
2022	—	0	258
2023	—	0	268
2024	—	0	204
2025	—	0	86
2026	—	0	—

https://510kreport.com/device/K850978 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850978: Olympus LF-1 Intubation Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850978

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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