510(k) Report

510(k) · Cleared

Cleared

Slater Sleeve

K926158510(k) TraditionalCleared Mar 19, 1993101-day reviewClass I21 CFR 868.5540

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

Tadco, Inc. · CCW Laryngoscope, Rigid

Cleared on Mar 19, 1993 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 19, 1993
Review
101 days
Class
Class I
Product code
CCW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK926158 Slater SleeveTadco, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK961832 Blue Ridge Products Laryngoscope Blade CoverBlue Ridge Medical, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K961832Blue Ridge Products Laryngoscope Blade CoverBlue Ridge Medical, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926158Slater SleeveTadco, Inc.1993—
+1K961832Blue Ridge Products Laryngoscope Blade CoverBlue Ridge Medical, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K926158, 1993–1996Source: 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 CCW? 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961832Blue Ridge Products Laryngoscope Blade CoverBlue Ridge Medical, Inc.19960

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, K961832 (Blue Ridge Medical, Inc., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CCW devices

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

FDA decisions per year · CCW

1in 2019

2007: 12012: 12014: 12017: 12019: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCW

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

Recalls per year · CCW

4in 2023

2007: 22010: 12011: 22012: 1, 1 Class I2013: 12014: 12015: 32016: 1, 1 Class I2017: 12019: 3, 1 Class I2023: 4, 1 Class I
2007high 4 (2023) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · CCW

1,569in 2025

2007: 62008: 142009: 172010: 262011: 212012: 712013: 3362014: 2022015: 3012016: 8252017: 4142018: 3832019: 3612020: 4962021: 4372022: 3242023: 3462024: 4732025: 1,569
2007high 1,569 (2025) · low 6 (2007)2025

MAUDE reports naming product code CCW, 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—26
20080—014
20090—017
20100—126
20110—221
20121—1 (1)71
20130—1336
20141—1202
20150—3301
20160—1 (1)825
20171—1414
20180—0383
20191—3 (1)361
20200—0496
20210—0437
20220—0324
20230—4 (1)346
20240—0473
20250—01,569
20260—0—
Cite this page

510(k) Report. “K926158: Slater Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926158

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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