510(k) · Cleared
Recalled · Class II · 2012Stryker Steri-Shield Surgical Apparel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · FYA Gown, Surgical
Cleared on Aug 28, 1995 after a 353-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 28, 1995
- Review
- 353 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 2
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK944393 Stryker Steri-Shield Surgical ApparelStryker Corp. · 1995
- Descendant · cites it directly · 5 of its ownK040764 Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004
- Descendant · 2 generations on · 3 of its ownK063005 Stryker T6 Hoods and TogasStryker Instruments · 2007
- Descendant · 3 generations on · 1 of its ownK073017 Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · Recalled
- Descendant · 4 generations on · 0 of its ownK141095 Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK140588 Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040764Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004 · cites it directly5descendants
- K063005Stryker T6 Hoods and TogasStryker Instruments · 2007 · 2 generations on3descendants
- K073017Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · 3 generations on1descendant
- K141095Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014 · 4 generations on0descendants
- K140588Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944393 | Stryker Steri-Shield Surgical Apparel | Stryker Corp. | 1995 | — |
| +1 | K040764 | Stryker T4 Hytrel Zipper Toga | Stryker Corp. | 2004 | — |
| +2 | K063005 | Stryker T6 Hoods and Togas | Stryker Instruments | 2007 | — |
| +3 | K073017 | Stryker Stri-Shield Flyte Togas | Stryker Instruments, Instruments Div. | 2007 | 1 |
| +4 | K141095 | Stryker Steri-Shield Flyte Hybrid Togas | Stryker Corporation | 2014 | — |
| +3 | K140588 | Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens | Stryker Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 3 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2012 | Class II | Z-1809-2012 | Process control | The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5… |
| Jun 1, 2012 | Class II | Z-1810-2012 | Process control | The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040764 (Stryker Corp., 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K944393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944393: Stryker Steri-Shield Surgical Apparel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944393
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026