510(k) · Cleared
Recalled · Class II · 2020Guangzhou Fortunique Drapes, Bags and Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Fortunique, Ltd. · MMP Cover, Barrier, Protective
Cleared on Nov 30, 2004 as substantially equivalent to K032065 (Medline Industries, Inc., 2003) and 5 other predicates after a 176-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 6 times.
- Decided
- Nov 30, 2004
- Review
- 176 days
- Class
- Class II
- Product code
- MMP
- Recalls
- 6
- Predicates
- 6
Its longest line of descent runs back 3 generations to K931417 (1995). 11 ancestors in all, the oldest K850959 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK931417 Sterile Equipment CoversCustom Medical Products, Ltd. · 1995
- 2 generations backK961699 Equipment CoversUnited States Surgical, A Division of Tyco Healthc · 1996
- 1 generation backK014239 Medsurg Equipment CoversInternational Medsurg Connection · 2002
- This deviceK041501 Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931417 | Sterile Equipment Covers | Custom Medical Products, Ltd. | 1995 | — |
| −2 | K961699 | Equipment Covers | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −1 | K014239 | Medsurg Equipment Covers | International Medsurg Connection | 2002 | — |
| 0 (this device) | K041501 | Guangzhou Fortunique Drapes, Bags and Covers | Guangzhou Fortunique, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K032065 | Medline Band Bags and Equipment CoversSummary page 1…Equipment drapes, bags and covers Classification: IL Predicate Devices: Medline Band Bags and Equipment Covers K032065 prirnaGARD Surgical Equipment Covers K022868… | 2003 |
| * | K022868 | Primagard Surgical Equipment DrapesSummary page 1…icate Devices: Medline Band Bags and Equipment Covers K032065 prirnaGARD Surgical Equipment Covers K022868 Coverall All Equipment Covers Banded Bags & Dome… | 2002 |
| * | K023540 | Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09Summary page 1…Coverall All Equipment Covers Banded Bags & Dome Bags, Various Models, Sterile and Non-sterile K023 540 International MedSurge Connections Equipment Covers -… | 2003 |
| * | K014239 | Medsurg Equipment CoversSummary page 1…d Non-sterile K023 540 International MedSurge Connections Equipment Covers - K014239 United States Surgical Corporation Equipment Covers… | 2002 |
| * | K961699 | Equipment CoversSummary page 1…K014239 United States Surgical Corporation Equipment Covers K961699 Pinnacle Products Coverall All, Chair Sleeve, Drape-it-All,… | 1996 |
| * | K962288 | Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest CoverSummary page 1…Pinnacle Products Coverall All, Chair Sleeve, Drape-it-All, Tray Sleeve and related products K962288 Guangzhou Forlunique, LiD June 4.2004 510(… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2020 | Class II | Z-1926-2020 | Under Investigation by firm | Sterile drapes packaged in an unsealed pouch. |
| Jun 27, 2017 | Class II | Z-3234-2017 | Under Investigation by firm | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| Jun 27, 2017 | Class II | Z-3236-2017 | Under Investigation by firm | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| Jun 27, 2017 | Class II | Z-3235-2017 | Under Investigation by firm | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| Jan 23, 2017 | Class II | Z-1409-2017 | Packaging process control | Sterility compromised due to breach in sterile barrier |
| Jan 23, 2017 | Class II | Z-1408-2017 | Packaging process control | Sterility compromised due to breach in sterile barrier |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K032065.
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?
Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact.
Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041501 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041501: Guangzhou Fortunique Drapes, Bags and Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041501
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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