510(k) · Cleared
ClearedMedsurg Equipment Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medsurg Connection · MMP Cover, Barrier, Protective
Cleared on Feb 19, 2002 as substantially equivalent to K962288 (Pinnacle Products, Inc., 1997) and 2 other predicates after a 55-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Feb 19, 2002
- Review
- 55 days
- Class
- Class II
- Product code
- MMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931417 (1995). 6 ancestors in all, the oldest K900093 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK931417 Sterile Equipment CoversCustom Medical Products, Ltd. · 1995
- 1 generation backK961699 Equipment CoversUnited States Surgical, A Division of Tyco Healthc · 1996
- This deviceK014239 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 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 |
|---|---|---|---|---|---|
| −2 | K931417 | Sterile Equipment Covers | Custom Medical Products, Ltd. | 1995 | — |
| −1 | K961699 | Equipment Covers | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962288 | Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest CoverSummary page 1…7) 856-0355 December 17, 2001 International Medsurg Connections Equipment Covers Equipment Covers Non-classified Cover-All, Drape-It-All - Pinnacle Products, Inc. - K962288 Equipment Covers - United States Surgical - K961699 Sterile Equipment Covers - Custom Medical Products, Ltd. - K931417 Descripti… | 1997 |
| * | K961699 | Equipment CoversSummary page 1…g Connections Equipment Covers Equipment Covers Non-classified Cover-All, Drape-It-All - Pinnacle Products, Inc. - K962288 Equipment Covers - United States Surgical - K961699 Sterile Equipment Covers - Custom Medical Products, Ltd. - K931417 Description: The International Medsurg Connections equipment… | 1996 |
| * | K931417 | Sterile Equipment CoversSummary page 1…over-All, Drape-It-All - Pinnacle Products, Inc. - K962288 Equipment Covers - United States Surgical - K961699 Sterile Equipment Covers - Custom Medical Products, Ltd. - K931417 Description: The International Medsurg Connections equipment covers are made of polyethylene. The covers are offered sterile and… | 1995 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K041501 (Guangzhou Fortunique, Ltd., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K962288.
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?
These equipment covers arc equipment drapes or drape accessories made of natural or synthetic materials intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
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/K014239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014239: Medsurg Equipment Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014239
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026