510(k) · Cleared
ClearedStryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · FXY Hood, Surgical
Cleared on Mar 21, 2020 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 21, 2020
- Review
- 22 days
- Class
- Class II
- Product code
- FXY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK200493 Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered…Stryker Corporation · 2020
- Descendant · cites it directly · 0 of its ownK241272 Stryker Steri-Shield 8 Surgical Hoods and TogasStryker Instruments · 2024
Most influential descendants
Showing 1 of 1 · See all- K241272Stryker Steri-Shield 8 Surgical Hoods and TogasStryker Instruments · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7… | Stryker Corporation | 2020 | — |
| +1 | K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 FXY? 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 FXY device
- #1 K222214 ViVi® Surgical Helmet System (ViVi® Helmet…score 6.5 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | 2024 | 0 |
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, K241272 (Stryker Instruments, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FXY devicesFXY Hood, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FXY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FXY
Too few FXY 510(k)s in any year since 2007 to give a median.
Recalls per year · FXY
No recall names FXY since 2007.
Adverse event reports per year · FXY
9in 2025
MAUDE reports naming product code FXY, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker T7 Togas and Stryker T7 Hoods are components of Stryker T7 Personal Protective Equipment (PPE). These surgical devices are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker T7 Togas and Stryker T7 Hoods are sterile, single use only devices.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K200493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200493: Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200493
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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