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

Instantron — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

129 daysmedian FDA review time

163 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K943398	THE BLENDTONE ROYALE	Instantron	1994-09-16	64
K943396	THE ELITE SPECTRUM	Instantron	1994-09-16	64
K943399	THE SS-99	Instantron	1994-09-16	64
K941227	SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL	Instantron	1994-08-18	163
K931062	THE VP500 EPILATOR	Instantron	1993-07-08	129
K931063	THE ELITE EPILATOR	Instantron	1993-07-08	129
K931064	THE BLENDTONE EPILATOR	Instantron	1993-07-08	129

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