510(k) · Cleared
ClearedFlyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · FXY Hood, Surgical
Cleared on Jun 26, 2014 as substantially equivalent to K063005 (Stryker Instruments, 2007) after a 111-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 26, 2014
- Review
- 111 days
- Class
- Class II
- Product code
- FXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944393 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944393 Stryker Steri-Shield Surgical ApparelStryker Corp. · 1995 · Recalled
- 2 generations backK040764 Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004
- 1 generation backK063005 Stryker T6 Hoods and TogasStryker Instruments · 2007
- This deviceK140588 Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944393 | Stryker Steri-Shield Surgical Apparel | Stryker Corp. | 1995 | 2 |
| −2 | K040764 | Stryker T4 Hytrel Zipper Toga | Stryker Corp. | 2004 | — |
| −1 | K063005 | Stryker T6 Hoods and Togas | Stryker Instruments | 2007 | — |
| 0 (this device) | K140588 | Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens | Stryker Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 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 FXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FXY device
- #1 K222214 ViVi® Surgical Helmet System (ViVi® Helmet…score 6.5 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K063005 | Stryker T6 Hoods and TogasSummary page 1…________Surgery Reason for 510(k) Special 510(k): Device Modification to Stryker Flyte Hood material Submission: Predicate SE Device(s): K063005, Stryker T6 Hoods and Togas Indications for Use: The Stryker Flyte Hybrid Hoods are devices within a personal prot… | 2007 |
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 19 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K063005.
How does its category compare?
All FXY devicesFXY Hood, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FXY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FXY
Too few FXY 510(k)s in any year since 2007 to give a median.
Recalls per year · FXY
No recall names FXY since 2007.
Adverse event reports per year · FXY
9in 2025
MAUDE reports naming product code FXY, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The devices are provided sterile and for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140588: Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140588
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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