510(k) · Cleared
ClearedConvertors Impervious Shoe Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · FXP Cover, Shoe, Operating-Room
Cleared on Mar 27, 1997 after a 21-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 27, 1997
- Review
- 21 days
- Class
- Class I
- Product code
- FXP
- 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 FXP? 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 |
|---|---|---|---|
| * | — | Kimberly-Clark X-Tra Traction Impervious Boot 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 FXP devicesFXP Cover, Shoe, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FXP
FDA has decided no FXP device since 2007.
Median 510(k) review, days · FXP
Too few FXP 510(k)s in any year since 2007 to give a median.
Recalls per year · FXP
No recall names FXP since 2007.
Adverse event reports per year · FXP
35in 2025
MAUDE reports naming product code FXP, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Convertors® Impervious Shoe Covers are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material
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/K970815 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970815: Convertors Impervious Shoe Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970815
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026