510(k) · Cleared
ClearedEquipment Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · MMP Cover, Barrier, Protective
Cleared on Aug 23, 1996 as substantially equivalent to K931417 (Custom Medical Products, Ltd., 1995) after a 113-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Aug 23, 1996
- Review
- 113 days
- Class
- Class II
- Product code
- MMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931417 (1995). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK931417 Sterile Equipment CoversCustom Medical Products, Ltd. · 1995
- This deviceK961699 Equipment CoversUnited States Surgical, A Division of Tyco Healthc · 1996
- Descendant · cites it directly · 1 of its ownK052395 Sterile Equipment CoversVolcano Corporation · 2005 · Recalled
- Descendant · cites it directly · 1 of its ownK014239 Medsurg Equipment CoversInternational Medsurg Connection · 2002
- Descendant · 2 generations on · 0 of its ownK121436 Das Medical Equipment DrapesDas Medical, LLC · 2013
- Descendant · cites it directly · 0 of its ownK041501 Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK023539 Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow…Valumed · 2002
Most influential descendants
Showing 5 of 5 · See all- K052395Sterile Equipment CoversVolcano Corporation · 2005 · cites it directly1descendant
- K014239Medsurg Equipment CoversInternational Medsurg Connection · 2002 · cites it directly1descendant
- K121436Das Medical Equipment DrapesDas Medical, LLC · 2013 · 2 generations on0descendants
- K041501Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004 · cites it directly0descendants
- K023539Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow, TransflowValumed · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931417 | Sterile Equipment Covers | Custom Medical Products, Ltd. | 1995 | — |
| 0 (this device) | K961699 | Equipment Covers | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| +1 | K052395 | Sterile Equipment Covers | Volcano Corporation | 2005 | 2 |
| +1 | K014239 | Medsurg Equipment Covers | International Medsurg Connection | 2002 | — |
| +2 | K121436 | Das Medical Equipment Drapes | Das Medical, LLC | 2013 | — |
| +1 | K041501 | Guangzhou Fortunique Drapes, Bags and Covers | Guangzhou Fortunique, Ltd. | 2004 | 6 |
| +1 | K023539 | Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow… | Valumed | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K931417 | Sterile Equipment CoversSummary page 1…000 Janet G. Johnson June 28, 1996 Equipment Covers Equipment Covers Auto Suture* ABBI* System Equipment Cover Sterile Equipment Covers by Custom Medical Products (K931417) Both-the Auto Suture* Equipment Covers** and the Sterile Equipment Covers by Custom Medical Products (K931417) consist of vario… | 1995 |
What descends from it? (5)
4 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)
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?
Both the Auto Suture* Equipment Covers** and the Sterile Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.
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/K961699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961699: Equipment Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961699
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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