510(k) · Cleared
Recalled · Class II · 2015Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinnacle Products, Inc. · MMP Cover, Barrier, Protective
Cleared on Jan 30, 1997 as substantially equivalent to K944198 (Hydro-Med Products, Inc., 1994) and 2 other predicates after a 230-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 30, 1997
- Review
- 230 days
- Class
- Class II
- Product code
- MMP
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 1 generation to K900093 (1990). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900093 Disposa-Shield (TM) Infection Control BarrierDentsply Intl. · 1990
- This deviceK962288 Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest CoverPinnacle Products, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK014239 Medsurg Equipment CoversInternational Medsurg Connection · 2002
- Descendant · cites it directly · 0 of its ownK041501 Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900093 | Disposa-Shield (TM) Infection Control Barrier | Dentsply Intl. | 1990 | — |
| 0 (this device) | K962288 | Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover | Pinnacle Products, Inc. | 1997 | — |
| +1 | K014239 | Medsurg Equipment Covers | International Medsurg Connection | 2002 | — |
| +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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944198 | Surgical Microscope DrapeSummary page 2…he market, some of which have been cleared by the 510(k) process. Some recent examples cleared under the code MMP are: Hydro-Med Product's "Surgical Microscope Drape," K-944198 and Cottrell's "Protouch Overglove," K-952241. Earlier examples include Dentsply's "Disposa-Shield", K-900093. End of Summary 1… | 1994 |
| * | K952241 | Protouch OvergloveSummary page 2…the 510(k) process. Some recent examples cleared under the code MMP are: Hydro-Med Product's "Surgical Microscope Drape," K-944198 and Cottrell's "Protouch Overglove," K-952241. Earlier examples include Dentsply's "Disposa-Shield", K-900093. End of Summary 10 | 1995 |
| * | K900093 | Disposa-Shield (TM) Infection Control BarrierSummary page 1…95-4246, "Classification Names for Medical Devices..." In the past, these devices were treated as accessories to the medical devices with which they were used, such as K-900093 which was cleared as an accessory to the dental handpiece, 76EFB CFR 872.4200. e V1. Performance Standard: None established unde… | 1990 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Feb 11, 2015 | Class II | Z-1291-2015 | Packaging | Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing… |
| Jan 30, 2015 | Class II | Z-1306-2015 | Use error | If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement. |
| Sep 20, 2011 | Class II | Z-0444-2013 | Error in labeling | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K014239 (International Medsurg Connection, 2002) has gone furthest, with 1 descendant 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?
to act as a physical barrier, augmenting existing infection control techniques and make clean-up and disinfection easier.
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/K962288 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962288: Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962288
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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