510(k) · Cleared
ClearedSurgical Drape Kit - D.I.R.R.a. SRL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D.I.R.R.a. S.R.L. · LRO General Surgery Tray
Cleared on Nov 30, 2004 as substantially equivalent to K934688 (Sterile Design, Inc., 1994) after a 218-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Nov 30, 2004
- Review
- 218 days
- Class
- Class II
- Product code
- LRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934688 (1994). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K110724Surgical Procedure PacksOmnia Spa · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934688 | Sterile Design | Sterile Design, Inc. | 1994 | — |
| 0 (this device) | K041080 | Surgical Drape Kit - D.I.R.R.a. SRL | D.I.R.R.a. S.R.L. | 2004 | — |
| +1 | K110724 | Surgical Procedure Packs | Omnia Spa | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 LRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRO device
- #1 K212258 Medline Cardiovascular Procedure Kitscore 2.5 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K934688 | Sterile DesignSummary page 1…75 780133 e-mail: matteo~dirra.it Date prepared: Jul 2 0th, 2004 / Rev. 2 Oct 26th,2004 Predicate devices - 510(K) Nr: k934688: The Surgical Drape Kit - produced by D.1.R.R.A. sr], is substantially equivalent to: Custom Surgical Pack - distributed by Nobel… | 1994 |
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 |
|---|---|---|---|
| K110724 | Surgical Procedure Packs | 2011 | 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?
- Its one ancestor has no recall.
- Of its descendants, K110724 (Omnia Spa, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LRO
Too few LRO 510(k)s in any year since 2007 to give a median.
Recalls per year · LRO
14in 2025
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
MAUDE reports naming product code LRO, 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 | — | 1 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 1 | 23 |
| 2011 | 0 | — | 11 | 17 |
| 2012 | 0 | — | 4 | 64 |
| 2013 | 0 | — | 11 (11) | 25 |
| 2014 | 0 | — | 59 (58) | 59 |
| 2015 | 0 | — | 5 | 628 |
| 2016 | 0 | — | 4 | 805 |
| 2017 | 0 | — | 29 | 523 |
| 2018 | 0 | — | 31 | 384 |
| 2019 | 0 | — | 4 | 406 |
| 2020 | 0 | — | 3 | 767 |
| 2021 | 1 | — | 3 | 920 |
| 2022 | 1 | — | 192 | 1,134 |
| 2023 | 0 | — | 18 (2) | 1,913 |
| 2024 | 0 | — | 60 (1) | 3,031 |
| 2025 | 0 | — | 14 (5) | 5,488 |
| 2026 | 0 | — | 75 (16) | — |
What is it indicated for?
The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as isolate a site of surgical incision from microbial or other contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041080: Surgical Drape Kit - D.I.R.R.a. SRL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041080
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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