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Resource Optimization & Innovation, LLC: FDA-registered device maker in Nashville, TN, United States, 10 510(k) clearances

Name: Resource Optimization & Innovation, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Resource Optimization & Innovation, LLC is registered with the FDA (registration 3004513970) in Nashville, TN, United States. It lists 38 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 8, 2023. 10 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004513970
Address: 1100 Dr Martin L King Jr Blvd Ste 1100, Nashville, TN, United States, 37203
Owner or operator: Resource Optimization & Innovation (10026387)
Roles: Repackager or relabeler
First device listed: August 6, 2008
Registered through: 2026
Brand names listed: Regard

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Bag, Polymeric Mesh, Pacemaker	DSW	1	Repackager or relabeler	accessdata.fda.gov
Band Or Belt, Pelvic Support	ISR	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Basin, Emesis	FNY	1	Repackager or relabeler	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Repackager or relabeler	accessdata.fda.gov
Cap, Surgical	FYF	1	Repackager or relabeler	accessdata.fda.gov
Central Venous Catheter Dressing Change Kit	PEZ	2	Repackager or relabeler	accessdata.fda.gov
Central Venous Catheter Tray	OFF	2	Repackager or relabeler	accessdata.fda.gov
Circumcision Tray	OHG	2	Repackager or relabeler	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Repackager or relabeler	accessdata.fda.gov
Device, Patient Transfer, Powered	FRZ	2	Repackager or relabeler	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Repackager or relabeler	accessdata.fda.gov
Drape, Patient, Ophthalmic	HMT	2	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Repackager or relabeler	accessdata.fda.gov
General Surgery Tray	LRO	2	Repackager or relabeler	accessdata.fda.gov
Gown, Isolation, Surgical	FYC	2	Repackager or relabeler	accessdata.fda.gov
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	QPC	2	Repackager or relabeler	accessdata.fda.gov
Gown, Surgical	FYA	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Repackager or relabeler	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Pad, Alcohol, Device Disinfectant	LKB	U	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Respirator, Surgical	MSH	2	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Repackager or relabeler	accessdata.fda.gov
Support, Patient Position	CCX	1	Repackager or relabeler	accessdata.fda.gov
Suture Kit	OVN	2	Repackager or relabeler	accessdata.fda.gov
Suture Removal Kit	MCZ	1	Repackager or relabeler	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Repackager or relabeler	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 8, 2023	K222128	Protective Gown AAMI Level 4	QPC	Substantially Equivalent	Kenpax International Limited	accessdata.fda.gov
May 11, 2022	K213001	Procedure Mask, Surgical Mask	FXX	Substantially Equivalent	A Plus International, Inc.	accessdata.fda.gov
November 7, 2021	K212504	Isolation Gown AAMI Level 3	FYC	Substantially Equivalent	Kenpax International Limited	accessdata.fda.gov
April 30, 2020	K192290	50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown	FYA	Substantially Equivalent	Xuchang Zhengde Environstar Medical Products Co., Ltd.	accessdata.fda.gov
November 20, 2018	K181857	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	LZA	Substantially Equivalent	Kossan International Sdn Bhd	accessdata.fda.gov
December 12, 2014	K141303	ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR	LZA	Substantially Equivalent	Zhida Glove Co., Ltd.	accessdata.fda.gov
November 12, 2009	K093169	SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)	FYA	Substantially Equivalent	A Plus International, Inc.	accessdata.fda.gov
June 9, 2008	K080366	DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES	DXQ	Substantially Equivalent	Zefon Intl.	accessdata.fda.gov
June 19, 2003	K031353	SOLUTION FACE MASKS	FXX	Substantially Equivalent	A Plus International, Inc.	accessdata.fda.gov
July 23, 1992	K921997	CUFF-M	DXQ	Substantially Equivalent	Lorin Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 28, 2022	89793	Class II	Terminated	Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site	A kit component, the PDI Prevantics Swab, was recalled.	accessdata.fda.gov
June 17, 2020	85907	Class II	Terminated	regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization c	The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.	accessdata.fda.gov
May 4, 2020	85632	Class II	Terminated	Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.	There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.	accessdata.fda.gov
March 21, 2019	82499	Class II	Ongoing	Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 Pneumosure High Flow II Tubeset, 0620 Pneumosure Heated Tubeset with RTP and 0620 Pneumosure High Flow Tubes	Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.	accessdata.fda.gov
September 25, 2017	78377	Class II	Ongoing	Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.	Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "Chl	accessdata.fda.gov
January 9, 2017	76255	Class II	Terminated	Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	accessdata.fda.gov
August 25, 2015	72053	Class II	Terminated	Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.	The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.	accessdata.fda.gov
August 25, 2015	72052	Class II	Terminated	Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.	Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.	accessdata.fda.gov
August 19, 2015	72008	Class II	Terminated	Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.	Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.	accessdata.fda.gov
April 22, 2015	71904	Class II	Terminated	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instrum	The kits contain an equipment glove component which may contain splits or holes compromising the sterility.	accessdata.fda.gov

Compare with other makers

Updated August 8, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.