510(k) · Cleared
ClearedDisposable Apron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrument Makar, Inc. · LYU Accessory, Surgical Apparel
Cleared on Feb 25, 1997 after a 116-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Feb 25, 1997
- Review
- 116 days
- Class
- Class I
- Product code
- LYU
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 LYU? 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K960264 | FDA’s K960264 is Conmed Ekg Stripper Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1996 |
| * | — | Sloan Medical, Disposable Surgical Jumpsuit Named without a submission number | |
| † | K955835 | Fluid Barrier Boot Knee & Ankle-High | 1996 |
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 LYU devicesLYU Accessory, Surgical Apparel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYU
FDA has decided no LYU device since 2007.
Median 510(k) review, days · LYU
Too few LYU 510(k)s in any year since 2007 to give a median.
Recalls per year · LYU
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYU
5in 2025
MAUDE reports naming product code LYU, 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 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 49 |
| 2017 | 0 | — | 1 | 11 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used in the hospital environment to protect the healthcare worker from the transfer of micro-organisms, blood, body fluids and particulate material between the worker and the patient.
The Disposable Apron is a disposable product intended for single use only.
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/K964364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964364: Disposable Apron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964364
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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