510(k) · Cleared
ClearedStryker Steri-Shield Flyte Hybrid Togas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · FYA Gown, Surgical
Cleared on Aug 26, 2014 as substantially equivalent to K073017 (Stryker Instruments, Instruments Div., 2007) after a 120-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 26, 2014
- Review
- 120 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944393 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK944393 Stryker Steri-Shield Surgical ApparelStryker Corp. · 1995 · Recalled
- 3 generations backK040764 Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004
- 2 generations backK063005 Stryker T6 Hoods and TogasStryker Instruments · 2007
- 1 generation backK073017 Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · Recalled
- This deviceK141095 Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944393 | Stryker Steri-Shield Surgical Apparel | Stryker Corp. | 1995 | 2 |
| −3 | K040764 | Stryker T4 Hytrel Zipper Toga | Stryker Corp. | 2004 | — |
| −2 | K063005 | Stryker T6 Hoods and Togas | Stryker Instruments | 2007 | — |
| −1 | K073017 | Stryker Stri-Shield Flyte Togas | Stryker Instruments, Instruments Div. | 2007 | 1 |
| 0 (this device) | K141095 | Stryker Steri-Shield Flyte Hybrid Togas | 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 FYA? 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 FYA device
- #1 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K073017 | Stryker Stri-Shield Flyte TogasSummary page 5…indications for use, nor the fundamental scientific technology. Predicate SE Device(s): Stryker Steri-Shield Flyte Togas (K073017) Indications for Use: The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal… | 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 4 companies; a new generation was cleared every 6.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FYA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FYA
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYA
1in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · FYA
14in 2025
MAUDE reports naming product code FYA, 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 | 6 | 110 | 2 | 8 |
| 2008 | 4 | 207 | 0 | 3 |
| 2009 | 6 | 98 | 0 | 18 |
| 2010 | 4 | 128 | 2 | 9 |
| 2011 | 8 | 141 | 0 | 16 |
| 2012 | 4 | 202 | 1 | 43 |
| 2013 | 2 | — | 0 | 71 |
| 2014 | 5 | 120 | 9 (9) | 42 |
| 2015 | 3 | 275 | 0 | 59 |
| 2016 | 3 | 155 | 0 | 43 |
| 2017 | 4 | 111 | 0 | 66 |
| 2018 | 2 | — | 1 | 98 |
| 2019 | 5 | 105 | 0 | 38 |
| 2020 | 7 | 114 | 40 | 31 |
| 2021 | 17 | 163 | 11 | 15 |
| 2022 | 24 | 177 | 2 | 4 |
| 2023 | 12 | 190 | 1 | 12 |
| 2024 | 5 | 163 | 0 | 27 |
| 2025 | 4 | 210 | 1 | 14 |
| 2026 | 9 | 198 | 2 | — |
What is it indicated for?
The Stryker Steri-Shield Flyte Hybrid Togas 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 togas are sterile and single use only.
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/K141095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141095: Stryker Steri-Shield Flyte Hybrid Togas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141095
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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