FDA product code LRR: First Aid Kit With Drug
LRR is the FDA product code for first aid kit with drug. It is a Not classified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 15 510(k) submissions under LRR, from 12 different applicants. The average 510(k) review took 138 days (median 86). FDA has posted 30 recalls for LRR devices, 6 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | First Aid Kit With Drug |
| Device class | Not classified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRR clearance
Top LRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fraass Survival Systems, Inc. | 3 | 1987-06-04 |
| Certified Safety Mfg., Inc. | 2 | 1994-10-03 |
| Baxter Healthcare Corp | 1 | 1997-03-17 |
| Water-Jel Technologies, Inc. | 1 | 1995-07-14 |
| Mind Mechanics, Inc. | 1 | 1994-03-01 |
7 more applicants have LRR clearances. See the full list in Caduvo.
Most recent LRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964029 | Baxter Healthcare Corp | EMERGENCY RELIEF KIT SYSTEM | 1997-03-17 | 161 |
| K952561 | Water-Jel Technologies, Inc. | WATER JEL BURN KIT | 1995-07-14 | 42 |
| K940249 | Certified Safety Mfg., Inc. | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | 1994-10-03 | 257 |
| K941311 | Certified Safety Mfg., Inc. | FIRST AID/TRUMA KIT | 1994-06-14 | 88 |
| K931058 | Mind Mechanics, Inc. | TICK-ATTACK(TM) KIT | 1994-03-01 | 365 |
Recalls for LRR devices
30 product recalls in 12 recall events; 6 initiated in the last five years and 3 still open. Most recent: 2026-03-27.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 5 |
| 2022 | 5 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LRR?
LRR is the FDA product code for first aid kit with drug. It is a Not classified device, reviewed by the General and Plastic Surgery panel.
What device class is LRR?
Not classified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRR?
Across 15 cleared submissions the average was 138 days from receipt to decision (median 86).
Which companies have the most LRR clearances?
Fraass Survival Systems, Inc. (3); Certified Safety Mfg., Inc. (2); Baxter Healthcare Corp (1); Water-Jel Technologies, Inc. (1); Mind Mechanics, Inc. (1).
Have LRR devices been recalled?
Yes: 30 product recalls across 12 recall events; the most recent began 2026-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LRR
- Run a recall and safety report across every LRR manufacturer
- Watch product code LRR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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