# K842648: General Surgery Tray

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Sep 20, 1984 after 38 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 33 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 3, 2024 · Class II · Z-0307-2025: 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 activati
- Oct 3, 2024 · Class II · Z-0308-2025: 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 activati
- Feb 13, 2024 · Class I · Z-1382-2024: 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: 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: 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 t
- May 30, 2023 · Class II · Z-2086-2023: 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: The custom procedure packs contain light handle covers that have been recalled by another firm.
- Dec 12, 2022 · Class II · Z-0927-2023: 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 
- Aug 12, 2022 · Class II · Z-1668-2022: Procedure packs contained a recalled product.
- Mar 3, 2022 · Class II · Z-0880-2022: 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: 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: 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: 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: 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: 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: 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: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1410-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1414-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1415-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1416-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1412-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1413-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1411-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1419-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Feb 4, 2020 · Class II · Z-1417-2020: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jun 18, 2019 · Class II · Z-1981-2019: 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 ster
- Jan 22, 2018 · Class II · Z-0637-2018: 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: 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
- Oct 16, 2017 · Class II · Z-0199-2018: 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: 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, 
- Aug 11, 2016 · Class II · Z-2679-2016: 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 recalle
- Aug 11, 2016 · Class II · Z-2678-2016: 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 recalle

Source page: https://510kreport.com/device/K842648
Methodology: https://510kreport.com/methodology