510(k) · Cleared
ClearedStryker T6 Hoods and Togas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · FYA Gown, Surgical
Cleared on Mar 23, 2007 as substantially equivalent to K040764 (Stryker Corp., 2004) and 1 other predicate after a 172-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 23, 2007
- Review
- 172 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944393 (1995). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944393 Stryker Steri-Shield Surgical ApparelStryker Corp. · 1995 · Recalled
- 1 generation backK040764 Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004
- This deviceK063005 Stryker T6 Hoods and TogasStryker Instruments · 2007
- Descendant · cites it directly · 1 of its ownK073017 Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK141095 Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014
- Descendant · cites it directly · 0 of its ownK140588 Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014
Most influential descendants
Showing 3 of 3 · See all- K073017Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · cites it directly1descendant
- K141095Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014 · 2 generations on0descendants
- K140588Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014 · cites it directly0descendants
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) | K063005 | Stryker T6 Hoods and Togas | Stryker Instruments | 2007 | — |
| +1 | K073017 | Stryker Stri-Shield Flyte Togas | Stryker Instruments, Instruments Div. | 2007 | 1 |
| +2 | K141095 | Stryker Steri-Shield Flyte Hybrid Togas | Stryker Corporation | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 2 | 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? (2)
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 T6 Hoods and Togas Classification: Sterile Surgical Gowns Equivalent to: K040764-Stryker Steri-shield T4 Hytrel K023 167-Allegiance Breathable Surgical Gown Device Description:… | 2004 |
| * | K023167 | Breathable Surgical GownSummary page 1…gas Classification: Sterile Surgical Gowns Equivalent to: K040764-Stryker Steri-shield T4 Hytrel K023 167-Allegiance Breathable Surgical Gown Device Description: Device History The Stryk… | 2002 |
What descends from it? (3)
2 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K073017 (Stryker Instruments, Instruments Div., 2007) has gone furthest, with 1 descendant of its own.
- 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 T6 Hood; T6 Hood, Peel-away; T6 Hood, S95; T6 Toga, Pullover; T6 Toga, Zippered; and T6 Toga with Peel-away 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/K063005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063005: Stryker T6 Hoods and Togas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063005
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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