FDA product code LRL: Cushion, Hemorrhoid
LRL is the FDA product code for cushion, hemorrhoid. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under LRL, from 3 different applicants. The average 510(k) review took 144 days (median 135).
Classification
| Field | Value |
|---|---|
| Device name | Cushion, Hemorrhoid |
| Device class | Unclassified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRL clearance
Top LRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hemaway, LLC | 1 | 2007-12-07 |
| Chi'Am Intl. | 1 | 1993-09-30 |
| Health Aid Products | 1 | 1987-06-23 |
Most recent LRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072690 | Hemaway, LLC | HEMAWAY SEAT | 2007-12-07 | 74 |
| K932396 | Chi'Am Intl. | PERI-COMFORT(TM) SEATING CUSHION | 1993-09-30 | 135 |
| K864470 | Health Aid Products | HEMOREST(TM) | 1987-06-23 | 223 |
Recalls for LRL devices
openFDA lists no recalls for product code LRL.
Frequently asked questions
What is FDA product code LRL?
LRL is the FDA product code for cushion, hemorrhoid. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.
What device class is LRL?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRL?
Across 3 cleared submissions the average was 144 days from receipt to decision (median 135).
Which companies have the most LRL clearances?
Hemaway, LLC (1); Chi'Am Intl. (1); Health Aid Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LRL
- Run a recall and safety report across every LRL manufacturer
- Watch product code LRL 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times