510(k) · Cleared
Recalled · Class II · 2021SmartGownTM surgical gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 200, Inc. · FYA Gown, Surgical
Cleared on May 21, 2015 as substantially equivalent to K012984 (Allegiance Healthcare Corp., 2001) after a 118-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.
- Decided
- May 21, 2015
- Review
- 118 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012984 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK012984 Breathable Impervious GownsAllegiance Healthcare Corp. · 2001
- This deviceK150151 SmartGownTM surgical gownCardinal Health 200, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012984 | Breathable Impervious Gowns | Allegiance Healthcare Corp. | 2001 | — |
| 0 (this device) | K150151 | SmartGownTM surgical gown | Cardinal Health 200, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K012984 | Breathable Impervious GownsSummary page 3…egan Road Waukegan, IL 60085 (847) 887-3323 (847) 785-2461 April 21, 2015 SmartGown™ surgical gown Class Il per 21 CFR § 878.4040 Surgical Apparel Surgical Gown FYA K012984 —Cardinal Health SmartGown™ Description The Cardinal Health SmartGown™ surgical gowns are identified by Regulati… | 2001 |
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 |
|---|---|---|---|---|
| Nov 2, 2021 | Class II | Z-0368-2022 | 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?
- Its one ancestor has no recall.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Cardinal Health SmartGown™ surgical gown surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The Cardinal Health SmartGown™ surgical gown surgical gown is a single use, disposable medical device provided sterile and non-sterile, This submission covers 12 models of Cardinal…
Read the full statement (117 words)
Cardinal Health SmartGown™ surgical gown surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The Cardinal Health SmartGown™ surgical gown surgical gown is a single use, disposable medical device provided sterile and non-sterile,
This submission covers 12 models of Cardinal Health SmartGown™ surgical gown, see Table 1. Each model is a multi-layer construction of a nonwoven outer layer, breathable film core and a nonwoven inner layer, and has been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150151: SmartGownTM 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/K150151
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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