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

LLN — Predicate Candidate Screening

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

266 daysmedian FDA review time

378 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K072882	PAIN VISION, MODEL PS-2100	Osachi Co., Ltd.	2009-01-08	457
K030829	VPT METER	Xilas Medical, Inc.	2003-12-05	266
K010981	GSA GENITO SENSORY ANALYZER	Medoc Ltd. Advanced Medical Systems	2001-09-20	171
K964622	MEDI-DX 7000	Neuro-Diagnostic Assoc.	1997-12-01	378
K964815	AP-4000, AIR PULSE SENSORY STIMULATOR	Pentax Precision Instrument Corp.	1997-09-04	279
K970180	VSA 3000 VIBRATORYN SENSORY ANALYZER	Eare Consulting Service	1997-04-25	98
K934368	NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001	Nk Biotechnical Engineering Co.	1994-08-11	338
K921560	VIBROTACTILE TESTER, MODEL NO. VTT-100	Topical Testing, Inc.	1992-10-30	212
K910624	CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4	Wr Medical Electronics Co.	1992-01-17	339
K872931	TECA/MEDELEC TTT THERMAL THRESHOLD TESTER	Teca, Inc.	1987-11-16	112
K863607	VIBRATRON II, VIBRATION SENSITIVITY TESTER	Sensortek, Inc.	1986-12-03	78
K853608	NEUROMETER	Neurotron, Inc.	1986-06-12	288
K843486	VIBRAMETER	Somedic AB	1984-12-24	109

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