510(k) · Cleared
Recalled · Class III · 2014Stryker Stri-Shield Flyte Togas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments, Instruments Div. · FYA Gown, Surgical
Cleared on Nov 30, 2007 as substantially equivalent to K063005 (Stryker Instruments, 2007) after a 36-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 30, 2007
- Review
- 36 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944393 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK073017 Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007
- Descendant · cites it directly · 0 of its ownK141095 Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014
Most influential descendants
Showing 1 of 1 · See all- K141095Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014 · cites it directly0descendants
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) | K073017 | Stryker Stri-Shield Flyte Togas | Stryker Instruments, Instruments Div. | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K063005 | Stryker T6 Hoods and Togas Our reading of the summary gave K003005, FDA’s number for Tissuelink Bipolar Forceps (Tissuelink Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker T6 Hoods and Togas”. | 2007 |
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 |
|---|---|---|---|
| K141095 | Stryker Steri-Shield Flyte Hybrid Togas | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2014 | Class III | Z-1077-2015 | Error in labeling | A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K141095 (Stryker Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K063005.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073017: Stryker Stri-Shield Flyte Togas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073017
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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