510(k) · Cleared
ClearedStryker T4 Hytrel (R) Togas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · LYU Accessory, Surgical Apparel
Cleared on Jun 22, 2001 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jun 22, 2001
- Review
- 16 days
- Class
- Class I
- Product code
- LYU
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK011755 Stryker T4 Hytrel (R) TogasStryker Corp. · 2001
- Descendant · cites it directly · 5 of its ownK040764 Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004
- Descendant · 2 generations on · 3 of its ownK063005 Stryker T6 Hoods and TogasStryker Instruments · 2007
- Descendant · 3 generations on · 1 of its ownK073017 Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · Recalled
- Descendant · 4 generations on · 0 of its ownK141095 Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK140588 Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040764Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004 · cites it directly5descendants
- K063005Stryker T6 Hoods and TogasStryker Instruments · 2007 · 2 generations on3descendants
- K073017Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · 3 generations on1descendant
- K141095Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014 · 4 generations on0descendants
- K140588Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011755 | Stryker T4 Hytrel (R) Togas | Stryker Corp. | 2001 | — |
| +1 | K040764 | Stryker T4 Hytrel Zipper Toga | Stryker Corp. | 2004 | — |
| +2 | K063005 | Stryker T6 Hoods and Togas | Stryker Instruments | 2007 | — |
| +3 | K073017 | Stryker Stri-Shield Flyte Togas | Stryker Instruments, Instruments Div. | 2007 | 1 |
| +4 | K141095 | Stryker Steri-Shield Flyte Hybrid Togas | Stryker Corporation | 2014 | — |
| +3 | K140588 | Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens | Stryker Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 3 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYU? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K040764 (Stryker Corp., 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LYU devicesLYU Accessory, Surgical Apparel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYU
FDA has decided no LYU device since 2007.
Median 510(k) review, days · LYU
Too few LYU 510(k)s in any year since 2007 to give a median.
Recalls per year · LYU
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYU
5in 2025
MAUDE reports naming product code LYU, 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 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 49 |
| 2017 | 0 | — | 1 | 11 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011755: Stryker T4 Hytrel (R) Togas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011755
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026