510(k) · Cleared
ClearedBlue Ridge Products Laryngoscope Blade Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Ridge Medical, Inc. · CCW Laryngoscope, Rigid
Cleared on Sep 6, 1996 as substantially equivalent to K926158 (Tadco, Inc., 1993) after a 116-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 6, 1996
- Review
- 116 days
- Class
- Class I
- Product code
- CCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926158 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926158 Slater SleeveTadco, Inc. · 1993
- This deviceK961832 Blue Ridge Products Laryngoscope Blade CoverBlue Ridge Medical, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926158 | Slater Sleeve | Tadco, Inc. | 1993 | — |
| 0 (this device) | K961832 | Blue Ridge Products Laryngoscope Blade Cover | Blue Ridge Medical, Inc. | 1996 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K926158 | Slater SleeveSummary page 1…) Legally Marketed Equivalent Device (Predicate Deviee): The predicate device is the Slater Sleeve, which is a substantially equivalent device with a cleared 510(k) (K # 926158). It is currently marketed by Tadeo. Inc. 4) A Description of the Device: This device is a molded plastic cover for a larvngosc… | 1993 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All CCW devicesCCW Laryngoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCW
1in 2019
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
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · CCW
1,569in 2025
MAUDE reports naming product code CCW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 6 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 1 | 26 |
| 2011 | 0 | — | 2 | 21 |
| 2012 | 1 | — | 1 (1) | 71 |
| 2013 | 0 | — | 1 | 336 |
| 2014 | 1 | — | 1 | 202 |
| 2015 | 0 | — | 3 | 301 |
| 2016 | 0 | — | 1 (1) | 825 |
| 2017 | 1 | — | 1 | 414 |
| 2018 | 0 | — | 0 | 383 |
| 2019 | 1 | — | 3 (1) | 361 |
| 2020 | 0 | — | 0 | 496 |
| 2021 | 0 | — | 0 | 437 |
| 2022 | 0 | — | 0 | 324 |
| 2023 | 0 | — | 4 (1) | 346 |
| 2024 | 0 | — | 0 | 473 |
| 2025 | 0 | — | 0 | 1,569 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961832: Blue Ridge Products Laryngoscope Blade Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961832
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026