510(k) · Cleared
Recalled · Class II · 2018Stryker T4 Hytrel Toga
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 Feb 2, 2007 as substantially equivalent to K040764 (Stryker Corp., 2004) and 2 other predicates after a 24-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 27 times.
- Decided
- Feb 2, 2007
- Review
- 24 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 27
- Predicates
- 3
Its longest line of descent runs back 2 generations to K944393 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944393 | Stryker Steri-Shield Surgical Apparel | Stryker Corp. | 1995 | 2 |
| −1 | K040764 | Stryker T4 Hytrel Zipper Toga | Stryker Corp. | 2004 | — |
| 0 (this device) | K070078 | Stryker T4 Hytrel Toga | Stryker Instruments, Instruments Div. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K040764 | Stryker T4 Hytrel Zipper TogaSummary page 1…1811755 Trade Name: Stryker T4 Hytrel Toga Common Name: Surgical gown Equivalent to: K040764-Stryker Steri-Shield T4 Hytrel Zipper Toga KO1 1755-Stryker Steri-Shield T4 Hytrel Toga… | 2004 |
| * | K011755 | Stryker T4 Hytrel (R) Togas | 2001 |
| * | K944393 | Stryker Steri-Shield Surgical ApparelSummary page 1…K040764-Stryker Steri-Shield T4 Hytrel Zipper Toga KO1 1755-Stryker Steri-Shield T4 Hytrel Toga K944393-Stryker Steri-Shield Protection System Device Description: The Stryker T4 Hytrel Toga is a single use sterile p… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2018 | Class II | Z-1510-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1506-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1502-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1507-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1509-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1504-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1503-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1500-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1505-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1501-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Feb 23, 2018 | Class II | Z-1508-2018 | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| May 23, 2013 | Class II | Z-1496-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1492-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1490-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1498-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1501-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1499-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1493-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1500-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1497-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1494-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1491-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1503-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1489-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1504-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1495-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
| May 23, 2013 | Class II | Z-1502-2013 | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year… |
The 5 latest of 27 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K040764.
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 T4 Hytrel Toga is a component 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 as stated in the FDA summary.
https://510kreport.com/device/K070078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070078: Stryker T4 Hytrel Toga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070078
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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