FDA product code LKX: Device, Thermal, Hemorrhoids
LKX is the FDA product code for device, thermal, hemorrhoids. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 18 510(k) submissions under LKX, from 17 different applicants. The average 510(k) review took 144 days (median 94).
Classification
| Field | Value |
|---|---|
| Device name | Device, Thermal, Hemorrhoids |
| Device class | Unclassified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LKX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 160 |
Top LKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. & Jp., Inc. | 2 | 1986-08-18 |
| Privi Medical Pte, Ltd. | 1 | 2018-01-10 |
| Cryotherapy Products, Inc. | 1 | 2012-05-03 |
| Lil Drug Store Products, Inc. | 1 | 2008-04-07 |
| Fama Holdings International Corp | 1 | 2005-09-30 |
12 more applicants have LKX clearances. See the full list in Caduvo.
Most recent LKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172358 | Privi Medical Pte, Ltd. | Instalief | 2018-01-10 | 160 |
| K113660 | Cryotherapy Products, Inc. | COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL | 2012-05-03 | 142 |
| K072414 | Lil Drug Store Products, Inc. | CRYOSTAT | 2008-04-07 | 223 |
| K042564 | Fama Holdings International Corp | HEMOR-RITE CRYOTHERAPHY | 2005-09-30 | 374 |
| K012746 | Behive, Ltd. | ICE BATON | 2001-11-14 | 90 |
Recalls for LKX devices
openFDA lists no recalls for product code LKX.
Frequently asked questions
What is FDA product code LKX?
LKX is the FDA product code for device, thermal, hemorrhoids. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.
What device class is LKX?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKX?
Across 18 cleared submissions the average was 144 days from receipt to decision (median 94).
Which companies have the most LKX clearances?
J. & Jp., Inc. (2); Privi Medical Pte, Ltd. (1); Cryotherapy Products, Inc. (1); Lil Drug Store Products, Inc. (1); Fama Holdings International Corp (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LKX
- Run a recall and safety report across every LKX manufacturer
- Watch product code LKX 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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