510(k) · Cleared
Recalled · 2006Laryngoscope Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truphatek, Ltd. · CCW Laryngoscope, Rigid
Cleared on Aug 19, 1988 after a 4-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 19, 1988
- Review
- 4 days
- Class
- Class I
- Product code
- CCW
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK883414 Laryngoscope BladesTruphatek, Ltd. · 1988
- Descendant · cites it directly · 0 of its ownK984101 FlexibladeArco Medic, Ltd. · 1999
Most influential descendants
Showing 1 of 1 · See all- K984101FlexibladeArco Medic, Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883414 | Laryngoscope Blades | Truphatek, Ltd. | 1988 | — |
| +1 | K984101 | Flexiblade | Arco Medic, Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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
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.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984101 | Flexiblade | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2006 | Not classified | Z-1225-06 | Component change control | Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984101 (Arco Medic, Ltd., 1999) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K883414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883414: Laryngoscope Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883414
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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