510(k) · Cleared
Recalled · Class II · 2022Maxair Surgical Helmet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Devices, Inc. · FYA Gown, Surgical
Cleared on Oct 18, 2004 as substantially equivalent to K993148 (Stryker Instruments, 1999) after a 236-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Oct 18, 2004
- Review
- 236 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993148 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993148 Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover TogaStryker Instruments · 1999
- This deviceK040485 Maxair Surgical Helmet SystemBio-Medical Devices, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993148 | Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga | Stryker Instruments | 1999 | — |
| 0 (this device) | K040485 | Maxair Surgical Helmet System | Bio-Medical Devices, Inc. | 2004 | — |
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 |
|---|---|---|---|
| * | K993148 | Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover TogaSummary page 1…fication: Class II Predicate Device: The predicate device is the Stryker T4 personal protection system (Ref:K993148) Substantial Equivalence: The MAXair® Surgical Helmet system is substantially equival… | 1999 |
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 9, 2022 | Class II | Z-0835-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K993148.
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 MAXair Surgical Helmet system 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 MAXair Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040485 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040485: Maxair Surgical Helmet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040485
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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