510(k) · Cleared
ClearedRusch Optosafe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · CAE Airway, Oropharyngeal, Anesthesiology
Cleared on Apr 19, 1996 as substantially equivalent to K830767 (Williams Airway Intubator, 1983) after a 94-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Apr 19, 1996
- Review
- 94 days
- Class
- Class I
- Product code
- CAE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830767 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK830767 Williams Airway IntubatorWilliams Airway Intubator · 1983
- This deviceK960240 Rusch OptosafeRusch Intl. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830767 | Williams Airway Intubator | Williams Airway Intubator | 1983 | — |
| 0 (this device) | K960240 | Rusch Optosafe | Rusch Intl. | 1996 | — |
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 CAE? 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 |
|---|---|---|---|
| * | K830767 | Williams Airway IntubatorSummary page 1…e an airway though the patient's mouth and allow fiberoptic tracheal intubation is substantially equivient in design, use and materials to the Williams Airway Intubator K830767 currently being marketed and sold in inter-state commerce. The device consists of a clear, implant tested, PVC tube formed into… | 1983 |
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.
How does its category compare?
All CAE devicesCAE Airway, Oropharyngeal, Anesthesiology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAE
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · CAE
Too few CAE 510(k)s in any year since 2007 to give a median.
Recalls per year · CAE
8in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CAE
59in 2025
MAUDE reports naming product code CAE, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 1 | 5 |
| 2009 | 0 | — | 13 | 5 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 20 | 19 |
| 2012 | 0 | — | 10 | 8 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 1 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 0 | — | 0 | 75 |
| 2018 | 0 | — | 1 | 56 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 0 | — | 4 | 51 |
| 2023 | 0 | — | 2 | 52 |
| 2024 | 0 | — | 8 | 59 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation.
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/K960240 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960240: Rusch Optosafe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960240
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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