FDA product code LRJ: Disinfectant, Medical Devices
LRJ is the FDA product code for disinfectant, medical devices. It is a Class I device, regulated under 21 CFR 880.6890 and reviewed by the General Hospital panel. FDA has cleared 73 510(k) submissions under LRJ, from 34 different applicants. The average 510(k) review took 194 days (median 80). FDA has posted 17 recalls for LRJ devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Disinfectant, Medical Devices |
| Device class | Class I |
| Regulation | 21 CFR 880.6890 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRJ clearance
Top LRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Central Solutions, Inc. | 7 | 1998-11-06 |
| Huntington Laboratories, Inc. | 6 | 1996-03-12 |
| Caltech Industries, Inc. | 5 | 1998-11-30 |
| Calgon Vestal Div. | 5 | 1994-06-17 |
| Sporicidin Intl. | 5 | 1993-02-12 |
29 more applicants have LRJ clearances. See the full list in Caduvo.
Most recent LRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992661 | Maril Products, Inc. | CONTROL III ELITE | 1999-09-14 | 36 |
| K991509 | Sultan Chemists, Inc. | PRO-PORTION CLEANER/DISINFECTANT | 1999-07-14 | 75 |
| K984485 | Chemlink Laboratories, LLC | MICROSTAT 2 | 1999-01-13 | 27 |
| K983947 | STERIS Corporation | AMERSE 2 | 1998-12-04 | 29 |
| K983869 | Caltech Industries, Inc. | DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH | 1998-11-30 | 28 |
Recalls for LRJ devices
17 product recalls in 11 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2026-06-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code LRJ?
LRJ is the FDA product code for disinfectant, medical devices. It is a Class I device, regulated under 21 CFR 880.6890 and reviewed by the General Hospital panel.
What device class is LRJ?
Class I, regulation 21 CFR 880.6890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRJ?
Across 73 cleared submissions the average was 194 days from receipt to decision (median 80).
Which companies have the most LRJ clearances?
Central Solutions, Inc. (7); Huntington Laboratories, Inc. (6); Caltech Industries, Inc. (5); Calgon Vestal Div. (5); Sporicidin Intl. (5).
Have LRJ devices been recalled?
Yes: 17 product recalls across 11 recall events; the most recent began 2026-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code LRJ
- Run a recall and safety report across every LRJ manufacturer
- Watch product code LRJ 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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