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

Future Impex Corp. — Predicate Candidate Screening

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

73 daysmedian FDA review time

196 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K861487	ST-90 SPIRO ANALIZER	Future Impex Corp.	1986-06-23	73
K854687	ERMA HB-METER MODEL 303N	Future Impex Corp.	1986-06-04	196
K854686	TE-25 COAGURO METER	Future Impex Corp.	1986-06-04	196
K854685	DIGITAL-9 KEY LEUCOCYTE COUNTER	Future Impex Corp.	1986-04-04	135
K854678	ERMA PC-602 PC-603 BLOOD CELL COUNTER	Future Impex Corp.	1986-02-24	81
K854677	ERMA PC-604 BLOOD CELL COUNTER	Future Impex Corp.	1986-02-24	96
K854679	PHOTIC-100 SPECTROPHOTOMETER	Future Impex Corp.	1986-02-20	92
K843934	MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT	Future Impex Corp.	1984-11-20	42
K843984	PM-80 PULMOTESTER	Future Impex Corp.	1984-10-24	13
K843700	ST-200A W/MAXIMAL VOLUNTARY VENTILLAT-	Future Impex Corp.	1984-10-24	34
K832431	FUKUNDA SANGYA UNITS PULMOTESTER PM60	Future Impex Corp.	1983-09-29	69
K832430	FUKUNDA SANGYO UNITS ELECTRONIC SPIRO	Future Impex Corp.	1983-09-29	69
K832432	SPIRO ANALYZER ST-100 AUTOMATIC SPIRO	Future Impex Corp.	1983-09-29	69
K832433	AUTOMATIC SPIROMETER ST-200	Future Impex Corp.	1983-09-29	69

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