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

Tannhut — Predicate Candidate Screening

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

28 daysmedian FDA review time

104 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K851858	FOLD AWAY HUT	Tannhut	1985-05-14	18
K851859	FACIAL/UPPER BODY UNIT	Tannhut	1985-05-14	18
K851255	SUN BEDS	Tannhut	1985-04-18	21
K840137	SILGMANN SOLARIUM S-TYPE 1218 COMBO	Tannhut	1984-04-23	104
K837283	UNKNOWN	Tannhut	1983-04-15	35
K812579	SUNTANNING HOME UNIT	Tannhut	1981-10-08	28
K802756	SEMI-OVAL MODULAR SUNTANNING BOOTH	Tannhut	1981-01-22	78

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