510(k) · Cleared
ClearedNovamed Mri Conditional Laryngoscope Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novamed, LLC · CCW Laryngoscope, Rigid
Cleared on Feb 9, 2007 as substantially equivalent to K041852 (Minrad, Inc., 2004) after an 85-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Feb 9, 2007
- Review
- 85 days
- Class
- Class I
- Product code
- CCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041852 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041852 MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002Minrad, Inc. · 2004
- This deviceK063477 Novamed Mri Conditional Laryngoscope SetNovamed, LLC · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002 | Minrad, Inc. | 2004 | — |
| 0 (this device) | K063477 | Novamed Mri Conditional Laryngoscope Set | Novamed, LLC | 2007 | — |
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 |
|---|---|---|---|
| * | K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002Summary page 1…me: Rigid Laryngoscope Device: NovaMed MR Conditional Predicate Devices: Minrad MR tested laryngoscope - K041852 [Device Description: The NovaMed MR Conditional laryngoscope handle, battery, and blades are standard blades and handles that h… | 2004 |
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.
- 2 other devices also cite its predicate K041852.
How does its category compare?
All CCW devicesCCW Laryngoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The NovaMed MRI Conditional laryngoscope set is used 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/K063477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063477: Novamed Mri Conditional Laryngoscope Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063477
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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