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

Bloomex International, Inc. · Predicate Candidate Screening

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

84 daysmedian FDA review time

489 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K942195	BX-400S	Bloomex International, Inc.	1995-08-14	489
K943185	BX-200 SC	Bloomex International, Inc.	1995-08-14	489
K842142	BX-400	Bloomex International, Inc.	1984-06-25	26
K841779	ELECTRONIC MUSCLE EXERCISE EQUIPMENT	Bloomex International, Inc.	1984-05-30	30
K832976	BX-600 EMS	Bloomex International, Inc.	1983-11-25	84
K822287	BX-500 ELECTRONIC MUSCLE EXERCISER	Bloomex International, Inc.	1982-10-13	75
K820080	BX-1000 ISOMATIC	Bloomex International, Inc.	1982-07-01	170
K821110	ELECTRONIC MUSCLE EXERCISER	Bloomex International, Inc.	1982-07-01	72
K813443	BX-400 SPORT	Bloomex International, Inc.	1982-03-08	89
K813410	BX-400 JESSE JIMBODY	Bloomex International, Inc.	1982-03-08	94
K811114	MODEL P-8 PROFESSIONAL	Bloomex International, Inc.	1981-11-23	214
K810975	MINITONE	Bloomex International, Inc.	1981-06-12	63
K810246	ELITE	Bloomex International, Inc.	1981-03-16	46
K810247	MBI-4	Bloomex International, Inc.	1981-03-10	40
K802304	SOLAR TONE	Bloomex International, Inc.	1980-12-01	69
K790120	SLENDERTONE	Bloomex International, Inc.	1979-05-07	104

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