510(k) · Cleared
ClearedMR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minrad, Inc. · CCW Laryngoscope, Rigid
Cleared on Aug 31, 2006 as substantially equivalent to K041852 (Minrad, Inc., 2004) after a 29-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Aug 31, 2006
- Review
- 29 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 deviceK062230 MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002Minrad, Inc. · 2006
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) | K062230 | MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002 | Minrad, Inc. | 2006 | — |
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? (3)
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…Laryngoscope, Rigid (21 CFR 868.5540, Product Code CCW) 5. Predicate Devices MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle (K041852) Laryngoscope, Welch Allyn Laryngoscope, Sun Med 6. Intended Use The MR Fiber Optic Intubating… | 2004 |
| * | — | Laryngoscope, Welch Allyn Named without a submission number | |
| * | — | Laryngoscope, Sun Med Named without a submission number |
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.
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 MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional 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/K062230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062230: MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062230
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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