510(k) · Cleared
ClearedViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thi Total Healthcare Innovation GmbH · FXY Hood, Surgical
Cleared on Oct 17, 2023 as substantially equivalent to K132386 (Zimmer, Inc., 2013) after a 449-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Oct 17, 2023
- Review
- 449 days
- Class
- Class II
- Product code
- FXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K102971 (2011). No later device cites it as a predicate yet.
- Root · 2 generations backK102971 Freedomaire Iii Surgical Helmet System Model 10322STKMicrotek Medical, Inc. · 2011
- 1 generation backK132386 Totalshield Surgical Helmet SystemZimmer, Inc. · 2013
- This deviceK222214 ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi®…Thi Total Healthcare Innovation GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K102971 | Freedomaire Iii Surgical Helmet System Model 10322STK | Microtek Medical, Inc. | 2011 | — |
| −1 | K132386 | Totalshield Surgical Helmet System | Zimmer, Inc. | 2013 | — |
| 0 (this device) | K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH | 2023 | — |
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 FXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K132386 | Totalshield Surgical Helmet SystemSummary page 5…Class II PRODUCT CODE: FXY III. PREDICATE DEVICES: Zimmer TotalShield™ Surgical Helmet System 510(k) Nr: K132386, Clearance date December 23rd, 2013 IV. DEVICE DESCRIPTION: The ViVi® Surgical Helmet System is intended to be worn by surgica… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 9.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K132386.
How does its category compare?
All FXY devicesFXY Hood, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ViVi® Hood is used with the ViVi® Helmet and/or ViVi® Helmet HPL as the ViVi® Surgical Helmet System to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The ViVi® Helmet and ViVi® Helmet HPL has a battery powered fan, which provides a continuous flow of air in the the ViVi® Hood.
The ViVi® Hood is a stand-alone head covers that may be worn with a separate surgical gown. The ViVi® Hood, must be worn over a ViVi® Helmet or ViVi® Helmet HPL.
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/K222214 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222214: ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222214
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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