LRRNot classified

First Aid Kit With Drug

Unknown

LRR is the FDA product code for First Aid Kit With Drug. FDA's definition for this code reads: "Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled...". As of 2026-09-10, FDA records hold 15 510(k) clearances under this code, the most recent dated 1997-03-17, and 30 recalls.

Classification record

Product code: LRR
Device name: First Aid Kit With Drug
FDA definition: Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Device class: Not classified
Review panel: Unknown
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 15
Ingested recalls: 30

Clearances, product code LRR

By decision year

15 clearances under product code LRR with a decision year between 1984 and 1997, 1987 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code LRR by decision year
Year	Clearances
1984	1
1987	3
1989	2
1990	1
1991	1
1993	2
1994	3
1995	1
1997	1

Applicants with the most clearances

Product code LRR

Applicants holding the most 510(k) clearances under product code LRR
Applicant	Clearances
Fraass Survival Systems, Inc.	3
Certified Safety Mfg Inc	2
Absentee Shawnee Bandage Group	1
Baxter Healthcare Corporation	1
Elwyn, Inc.	1
Hisler-Radke, Inc.	1
James Alexander Corp.	1
Mind Mechanics, Inc.	1
Polymint Industrial Co., Ltd.	1
Reed Products, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 140 companies shown, in name order