510(k) · Cleared
Recalled · Class II · 2023Medline Band Bags and Equipment Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · MMP Cover, Barrier, Protective
Cleared on Sep 22, 2003 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 22, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- MMP
- Recalls
- 2
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK032065 Medline Band Bags and Equipment CoversMedline Industries, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK050322 Microtek Equipment DrapesMicrotek Medical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK081476 Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs · 2008
- Descendant · cites it directly · 1 of its ownK052395 Sterile Equipment CoversVolcano Corporation · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK141438 Whitney Medical Solutions EshieldWhitney Medical Solutions · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K050322Microtek Equipment DrapesMicrotek Medical, Inc. · 2005 · cites it directly9descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 2 generations on2descendants
- K081476Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs · 2008 · 2 generations on1descendant
- K052395Sterile Equipment CoversVolcano Corporation · 2005 · cites it directly1descendant
- K141438Whitney Medical Solutions EshieldWhitney Medical Solutions · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032065 | Medline Band Bags and Equipment Covers | Medline Industries, Inc. | 2003 | — |
| +1 | K050322 | Microtek Equipment Drapes | Microtek Medical, Inc. | 2005 | 17 |
| +2 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +2 | K081476 | Surgical Concept Designs Positionor Surgical Drape | Surgical Concept Designs | 2008 | — |
| +1 | K052395 | Sterile Equipment Covers | Volcano Corporation | 2005 | 2 |
| +2 | K141438 | Whitney Medical Solutions Eshield | Whitney Medical Solutions | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2023 | Class II | Z-2154-2023 | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| May 15, 2023 | Class II | Z-2290-2023 | Nonconforming Material/Component | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050322 (Microtek Medical, Inc., 2005) has gone furthest, with 9 descendants of its own.
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?
Medline Band Bags and 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 have no patient contact.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032065: Medline Band Bags and Equipment Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032065
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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