Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LKX — Predicate Candidate Screening

18 FDA 510(k) clearances under this product code; the 50 most recent screened below.

96 daysmedian FDA review time

349 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K172358	Instalief	Privi Medical Pte, Ltd.	2018-01-10	160
K113660	COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL	Cryotherapy Products, Inc.	2012-05-03	142
K072414	CRYOSTAT	Lil Drug Store Products, Inc.	2008-04-07	223
K042564	HEMOR-RITE CRYOTHERAPHY	Fama Holdings International Corp	2005-09-30	374
K012746	ICE BATON	Behive, Ltd.	2001-11-14	90
K981428	ANU ICE	Cryoptherapy Pain Relief Products, Inc.	1998-07-07	78
K973590	HEMORRELIEF DEVICE	A.Stein - Regulatory Affairs Consulting	1998-02-05	136
K944874	ZEROID HEMORRHOIDAL DEVICE	Medical Appliance Research Corp.	1995-08-07	308
K921189	THERMA-H	Zewa AG	1992-08-31	181
K905276	THERMA-H	Kure Swiss Medical AG Corp.	1991-11-07	349
K883984	HEMORX COLD PACK	Bio-Dyne, Inc.	1988-12-22	93
K862490	ANU-RX	J. & Jp., Inc.	1986-08-18	48
K855150	HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS	Hpk International, Inc.	1986-04-01	96
K854569	HEMOR-ICE	Technology 2000	1986-02-05	83
K852679	MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE	J. & Jp., Inc.	1985-08-09	45
K822649	DEVICE FOR THE TREATMENT OF HEMORRHOIDS	Dunmore Corp.	1982-11-03	63
K822217	THERMOTHERAPY	Luther Medical Products, Inc.	1982-09-24	60
K812567	RELIEF	American Pharmaceutical Co., Inc.	1981-11-10	62

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda