510(k) · Cleared
ClearedSnap Kover, Model 01-2020; Snap Kaps, Model 03-KP09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valumed · MMP Cover, Barrier, Protective
Cleared on Feb 4, 2003 as substantially equivalent to K931417 (Custom Medical Products, Ltd., 1995) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Feb 4, 2003
- Review
- 105 days
- Class
- Class II
- Product code
- MMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K850959 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK850959 Equipment Snap KoversAdvance Medical Designs, Inc. · 1985 · Recalled
- This deviceK023540 Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09Valumed · 2003
- Descendant · cites it directly · 0 of its ownK041501 Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K041501Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850959 | Equipment Snap Kovers | Advance Medical Designs, Inc. | 1985 | 1 |
| 0 (this device) | K023540 | Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09 | Valumed | 2003 | — |
| +1 | K041501 | Guangzhou Fortunique Drapes, Bags and Covers | Guangzhou Fortunique, Ltd. | 2004 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 MMP? 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? (3)
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 |
|---|---|---|---|
| * | K931417 | Sterile Equipment CoversSummary page 1…Equipment Covers PROPRIETARY NAME: Cover All Equipment Covers PREDICATE DEVICES: Sterile Equipment Covers - Custom Medical Products - K93 14 17 Equipment Covers - United States Surgical - KO64699 Equipment Snap Colrers - Advance Mcdical Designs -IC850959 DEVICE DESCRIPTIO… | 1995 |
| Kept off the family tree | K064699 | Equipment Covers Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K850959 | Equipment Snap KoversSummary page 1…Producls(K93 14 17). Equipment Covers bv United States Surgical(K961699) and tlie Equipment Snap Covers b) Advance Medical Designs(K850959) consist of lwious sizes and shapes of polb,ethylene covcrs tliat ;ire positioned on surgic… | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041501 | Guangzhou Fortunique Drapes, Bags and Covers | 2004 | 0 |
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?
How does its category compare?
All MMP devicesMMP Cover, Barrier, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMP
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · MMP
Too few MMP 510(k)s in any year since 2007 to give a median.
Recalls per year · MMP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMP
1in 2025
MAUDE reports naming product code MMP, 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 | 0 |
| 2008 | 0 | — | 5 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The various sizes of Polyethylene Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and do not have patient contact.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023540: Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023540
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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