510(k) · Cleared
ClearedAqua Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boyd Industries, Inc. · GEY Motor, Surgical Instrument, Ac-Powered
Cleared on Aug 14, 1997 after a 79-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 14, 1997
- Review
- 79 days
- Class
- Class I
- Product code
- GEY
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 GEY? 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 |
|---|---|---|---|
| * | — | Podo Spray Named without a submission number |
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.
How does its category compare?
All GEY devicesGEY Motor, Surgical Instrument, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEY
FDA has decided no GEY device since 2007.
Median 510(k) review, days · GEY
Too few GEY 510(k)s in any year since 2007 to give a median.
Recalls per year · GEY
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEY
965in 2025
MAUDE reports naming product code GEY, 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 | 19 |
| 2008 | 0 | — | 1 | 9 |
| 2009 | 0 | — | 1 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 1 | 14 |
| 2013 | 0 | — | 2 | 901 |
| 2014 | 0 | — | 0 | 738 |
| 2015 | 0 | — | 0 | 2,013 |
| 2016 | 0 | — | 0 | 1,943 |
| 2017 | 0 | — | 0 | 2,119 |
| 2018 | 0 | — | 0 | 1,288 |
| 2019 | 0 | — | 0 | 1,131 |
| 2020 | 0 | — | 0 | 952 |
| 2021 | 0 | — | 0 | 1,145 |
| 2022 | 0 | — | 0 | 1,360 |
| 2023 | 0 | — | 0 | 1,444 |
| 2024 | 0 | — | 0 | 1,447 |
| 2025 | 0 | — | 0 | 965 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.
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/K971941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971941: Aqua Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971941
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026