510(k) Report

510(k) · Cleared

Cleared

AO Flexible Laryngoscope, #LS-7

K802331510(k) TraditionalCleared Oct 10, 198017-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

American Optical Corp. · CAL Laryngoscope, Non-Rigid

Cleared on Oct 10, 1980 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 10, 1980
Review
17 days
Class
Class I
Product code
CAL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K802331Source: FDA 510(k) database · 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 CAL? 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?

No later submission names this one as a predicate yet.

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.

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

2013: 12021: 1
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

2008: 32009: 12010: 492011: 92012: 102013: 212014: 212015: 42016: 72017: 102018: 42019: 12020: 22021: 602022: 2582023: 2682024: 2042025: 86
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—03
20090—01
20100—049
20110—09
20120—010
20130—121
20140—021
20150—04
20160—07
20170—010
20180—04
20190—01
20200—02
20210—160
20220—0258
20230—0268
20240—0204
20250—086
20260—0—

More from American Optical Corp.

35 FDA decisions under this applicant name. See the company

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  • K931354P4000 PhacoemulsifierAmerican Optical Corp. · 1994
  • K931358AORP4000 Reusable PakAmerican Optical Corp. · 1994
  • K931357AOD4000 Disposable PakAmerican Optical Corp. · 1994

Recent decisions in CAL

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  • K872895Haemonetics Cell Saver Mini Saver Auto. Blood Sys.Haemonetics Corp. · 1988
  • K852994Reichert Flexible Laryngoscope, Model LS-11Reichert-Jung, Inc. · 1985
  • K850978Olympus LF-1 Intubation ScopeOlympus Corp. · 1985

https://510kreport.com/device/K802331 · printed Nov 5, 2026

Cite this page

510(k) Report. “K802331: AO Flexible Laryngoscope, #LS-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K802331

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