510(k) · Cleared
ClearedTotalshield Surgical Helmet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · FYA Gown, Surgical
Cleared on Dec 23, 2013 as substantially equivalent to K102971 (Microtek Medical, Inc., 2011) after a 144-day review. Its family tree reaches back 1 generation to 2011. 2 later devices descend from it.
- Decided
- Dec 23, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102971 (2011). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK102971 Freedomaire Iii Surgical Helmet System Model 10322STKMicrotek Medical, Inc. · 2011
- This deviceK132386 Totalshield Surgical Helmet SystemZimmer, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK222214 ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi®…Thi Total Healthcare Innovation GmbH · 2023
- Descendant · cites it directly · 0 of its ownK142166 Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet…Zimmer, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See all- K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbH · 2023 · cites it directly0descendants
- K142166Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet Advanced Helmet W/Led…Zimmer, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102971 | Freedomaire Iii Surgical Helmet System Model 10322STK | Microtek Medical, Inc. | 2011 | — |
| 0 (this device) | K132386 | Totalshield Surgical Helmet System | Zimmer, Inc. | 2013 | — |
| +1 | K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH | 2023 | — |
| +1 | K142166 | Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet Advanced… | Zimmer, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K102971 | Freedomaire Iii Surgical Helmet System Model 10322STKSummary page 1…- Surgical Apparel Predicate Device: Microtek Medical Freedomaire Ill Surgical Helmet System Model IO322STK. K102971, cleared 02/23/2011 Device Description: The Tota/Shield Zippered Surgi… | 2011 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K222214 (Thi Total Healthcare Innovation GmbH, 2023) has gone furthest, with 0 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. 2013, 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?
The TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood is for use with the TotalShield Surgical Helmet and/or TotalShield Advanced Surgical Helmet with LED lighting as TotalShield Surgical Helmet System that is intended to be worn by surgical personnel 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132386: Totalshield Surgical Helmet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132386
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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