Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

IKE — Predicate Candidate Screening

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

57 daysmedian FDA review time

333 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K060125	SONIC PALPOMETER	Palpometer Systems, Inc.	2006-03-16	57
K954670	PRESSORE MONITOR	Cleveland Medical Devices, Inc.	1995-10-30	20
K915369	THE EQUALIZER	Advanced Rehabilitative Technology, Inc.	1993-03-22	481
K915326	PORTABLE LIMB LOAD MONITOR (BMLLM-100)	Bar Med Pty , Ltd.	1992-10-20	333
K920091	IOWA ORAL PERFORMANCE ISNTRUMENT	Breakthrough, Inc.	1992-05-20	133
K915897	FPL	Wrm Computers	1992-04-07	134
K914780	TALLEY SD.500 SKIN PRESSURE EVALUATOR	Talley Group, Ltd.	1991-12-19	57
K902967	MICRO-EMED-SYSTEM	Novel Electronics, Inc.	1990-09-17	73
K880912	DYNATRON 2000	Dynatronics Corp.	1988-03-15	12
K875103	BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1	Shield Computers , Ltd.	1988-01-20	41
K871690	EMED-F-SYSTEM	Novel GmbH	1987-05-15	16
K864499	PODOSCOPE	Broadwest Corp.	1987-02-04	82
K864569	PODODIGITAL	Broadwest Corp.	1987-02-04	76
K844202	MOSS LIMB LOAD MONITOR LM101-1	Moss Rehabilation Hospital	1984-11-27	28
K843634	ASC 4080 SYSTEM	Atlantis Scientific Corp.	1984-11-08	52

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