510(k) · Cleared
ClearedAirtraq SP Airtraq Avant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prodol Meditec, Ltd. · CCW Laryngoscope, Rigid
Cleared on Jun 21, 2012 as substantially equivalent to K062523 (Truphatek International, Ltd., 2006) after a 44-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Jun 21, 2012
- Review
- 44 days
- Class
- Class I
- Product code
- CCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041852 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K062523 | Tru-MR Laryngoscope SetSummary page 1…CW 21 CFR 868.5540 Class I Predicate Devices: Truphatek Tru-MRTM - K062523 Device Description: Airtraq®& Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the… | 2006 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K062523.
How does its category compare?
All CCW devicesCCW Laryngoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121378: Airtraq SP Airtraq Avant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121378
Report an extraction error
Are you the manufacturer?
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