510(k) · Cleared
ClearedFreedomaire Iii Surgical Helmet System Model 10322STK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microtek Medical, Inc. · FYA Gown, Surgical
Cleared on Feb 23, 2011 after a 140-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Feb 23, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK102971 Freedomaire Iii Surgical Helmet System Model 10322STKMicrotek Medical, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK132386 Totalshield Surgical Helmet SystemZimmer, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK222214 ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi®…Thi Total Healthcare Innovation GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK142166 Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet…Zimmer, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K132386Totalshield Surgical Helmet SystemZimmer, Inc. · 2013 · cites it directly2descendants
- K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbH · 2023 · 2 generations on0descendants
- K142166Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet Advanced Helmet W/Led…Zimmer, Inc. · 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) | K102971 | Freedomaire Iii Surgical Helmet System Model 10322STK | Microtek Medical, Inc. | 2011 | — |
| +1 | K132386 | Totalshield Surgical Helmet System | Zimmer, Inc. | 2013 | — |
| +2 | K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132386 | Totalshield Surgical Helmet System | 2013 | 2 |
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?
- Of its descendants, K132386 (Zimmer, Inc., 2013) has gone furthest, with 2 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. 2011, 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 Freedomaire III Surgical Helmet System 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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102971: Freedomaire Iii Surgical Helmet System Model 10322STK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102971
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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