LKX
18 FDA 510(k) clearances · Product code
96 daysmedian time to decision
349 days90th percentile
18clearances measured
FDA profile
- Official device name
- Device, Thermal, Hemorrhoids
- Device class
- Unclassified
- Medical specialty
- Unknown
- Adverse events (MAUDE)
- 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Instalief (K172358) | Privi Medical Pte, Ltd. | 2018-01-10 |
| COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (K113660) | Cryotherapy Products, Inc. | 2012-05-03 |
| CRYOSTAT (K072414) | Lil Drug Store Products, Inc. | 2008-04-07 |
| HEMOR-RITE CRYOTHERAPHY (K042564) | Fama Holdings International Corp | 2005-09-30 |
| ICE BATON (K012746) | Behive, Ltd. | 2001-11-14 |
| ANU ICE (K981428) | Cryoptherapy Pain Relief Products, Inc. | 1998-07-07 |
| HEMORRELIEF DEVICE (K973590) | A.Stein - Regulatory Affairs Consulting | 1998-02-05 |
| ZEROID HEMORRHOIDAL DEVICE (K944874) | Medical Appliance Research Corp. | 1995-08-07 |
| THERMA-H (K921189) | Zewa AG | 1992-08-31 |
| THERMA-H (K905276) | Kure Swiss Medical AG Corp. | 1991-11-07 |
| HEMORX COLD PACK (K883984) | Bio-Dyne, Inc. | 1988-12-22 |
| ANU-RX (K862490) | J. & Jp., Inc. | 1986-08-18 |
| HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS (K855150) | Hpk International, Inc. | 1986-04-01 |
| HEMOR-ICE (K854569) | Technology 2000 | 1986-02-05 |
| MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE (K852679) | J. & Jp., Inc. | 1985-08-09 |
| DEVICE FOR THE TREATMENT OF HEMORRHOIDS (K822649) | Dunmore Corp. | 1982-11-03 |
| THERMOTHERAPY (K822217) | Luther Medical Products, Inc. | 1982-09-24 |
| RELIEF (K812567) | American Pharmaceutical Co., Inc. | 1981-11-10 |
Track LKX automatically
Every clearance here is in the API, with alerts when new ones post.