510(k) · Cleared
Recalled · Class I · 2024General Surgery Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · LRO General Surgery Tray
Cleared on Sep 20, 1984 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled 33 times, including 3 Class I recalls.
- Decided
- Sep 20, 1984
- Review
- 38 days
- Class
- Class II
- Product code
- LRO
- Recalls
- 33 (3 Class I)
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 2.4 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2024 | Class II | Z-0307-2025 | Under Investigation by firm | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged… |
| Oct 3, 2024 | Class II | Z-0308-2025 | Under Investigation by firm | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged… |
| Feb 13, 2024 | Class I | Z-1382-2024 | Other | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. |
| Nov 22, 2023 | Class II | Z-0622-2024 | Device Design | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. |
| Sep 18, 2023 | Class II | Z-0116-2024 | Nonconforming Material/Component | DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer… |
| May 30, 2023 | Class II | Z-2086-2023 | Process control | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| Apr 17, 2023 | Class II | Z-1691-2023 | Nonconforming Material/Component | The custom procedure packs contain light handle covers that have been recalled by another firm. |
| Dec 12, 2022 | Class II | Z-0927-2023 | Packaging change control | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may… |
| Aug 12, 2022 | Class II | Z-1668-2022 | Material/Component Contamination | Procedure packs contained a recalled product. |
| Mar 3, 2022 | Class II | Z-0880-2022 | Process control | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. |
| Mar 3, 2022 | Class II | Z-0879-2022 | Process control | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. |
| Sep 2, 2021 | Class I | Z-2499-2021 | Nonconforming Material/Component | DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids. |
| May 14, 2021 | Class I | Z-1832-2021 | Nonconforming Material/Component | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine |
| Jan 25, 2021 | Class II | Z-1140-2021 | Process control | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker. |
| Jan 25, 2021 | Class II | Z-1138-2021 | Process control | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker. |
| Jan 25, 2021 | Class II | Z-1139-2021 | Process control | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker. |
| Feb 4, 2020 | Class II | Z-1418-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1410-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1414-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1415-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1416-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1412-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1413-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1411-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1419-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Feb 4, 2020 | Class II | Z-1417-2020 | Environmental control | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jun 18, 2019 | Class II | Z-1981-2019 | Nonconforming Material/Component | Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product. |
| Jan 22, 2018 | Class II | Z-0637-2018 | Process change control | DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve. |
| Dec 19, 2017 | Class II | Z-0334-2018 | Nonconforming Material/Component | DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline… |
| Oct 16, 2017 | Class II | Z-0199-2018 | Nonconforming Material/Component | Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date. |
| Jan 25, 2017 | Class III | Z-1247-2017 | Other | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest… |
| Aug 11, 2016 | Class II | Z-2679-2016 | Nonconforming Material/Component | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the… |
| Aug 11, 2016 | Class II | Z-2678-2016 | Nonconforming Material/Component | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the… |
The 5 latest of 33 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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
2007high 1 (2021) · low 0 (2007)2026
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
2007high 192 (2022) · low 0 (2008)2026
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
2007high 5,488 (2025) · low 5 (2009)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) | — |
https://510kreport.com/device/K842648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K842648: General Surgery Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K842648
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026