510(k) · Cleared
ClearedGreatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson Greatbatch Technologies, Inc. · CCW Laryngoscope, Rigid
Cleared on Nov 19, 1997 after a 274-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 19, 1997
- Review
- 274 days
- Class
- Class I
- Product code
- CCW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970619 Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope HandleWilson Greatbatch Technologies, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK062231 MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001Minrad, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062231MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001Minrad, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970619 | Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle | Wilson Greatbatch Technologies, Inc. | 1997 | — |
| +1 | K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001 | Minrad, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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 |
|---|---|---|---|
| * | — | Fiber Optic Laryngoscope Named without a submission number | |
| * | — | Sun Lite™ Laryngoscope Named without a submission number | |
| * | — | Heine Fiber Optic Laryngoscope Named without a submission number |
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 |
|---|---|---|---|
| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001 | 2006 | 0 |
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?
- Of its descendants, K062231 (Minrad, Inc., 2006) 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 | — |
What is it indicated for?
The Greatbatch Scientific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.
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/K970619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970619: Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970619
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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