510(k) · Cleared
Recalled · Class II · 2021Breathable Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · FYA Gown, Surgical
Cleared on Oct 2, 2002 after a 9-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 2, 2002
- Review
- 9 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 3
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK023167 Breathable Surgical GownAllegiance Healthcare Corp. · 2002
- Descendant · cites it directly · 3 of its ownK063005 Stryker T6 Hoods and TogasStryker Instruments · 2007
- Descendant · 2 generations on · 1 of its ownK073017 Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · Recalled
- Descendant · 3 generations on · 0 of its ownK141095 Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK140588 Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014
Most influential descendants
Showing 4 of 4 · See all- K063005Stryker T6 Hoods and TogasStryker Instruments · 2007 · cites it directly3descendants
- K073017Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · 2 generations on1descendant
- K141095Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014 · 3 generations on0descendants
- K140588Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023167 | Breathable Surgical Gown | Allegiance Healthcare Corp. | 2002 | — |
| +1 | K063005 | Stryker T6 Hoods and Togas | Stryker Instruments | 2007 | — |
| +2 | K073017 | Stryker Stri-Shield Flyte Togas | Stryker Instruments, Instruments Div. | 2007 | 1 |
| +3 | K141095 | Stryker Steri-Shield Flyte Hybrid Togas | Stryker Corporation | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Convertors® Breathable Surgical Gowns Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063005 | Stryker T6 Hoods and Togas | 2007 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2021 | Class II | Z-0369-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0370-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0371-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063005 (Stryker Instruments, 2007) has gone furthest, with 3 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 | — |
What is it indicated for?
The Convertors® Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023167: Breathable Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023167
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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