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

Icor AB — Predicate Candidate Screening

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

78 daysmedian FDA review time

245 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K954402	ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)	Icor AB	1996-05-22	245
K953507	TYPE 1 & 2 (HUMIDAIR I & II)	Icor AB	1995-09-07	43
K952325	ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)	Icor AB	1995-07-31	74
K952823	FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T W	Icor AB	1995-07-13	23
K941987	HEAT AND MOISTURE EXCHANGERS AND FILTERS	Icor AB	1994-08-15	112
K940041	COLIBRI	Icor AB	1994-07-27	204
K941436	AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF	Icor AB	1994-06-08	76
K925622	FHB, FHB-T, FHBFLEX, FHBFLEX-T	Icor AB	1993-05-26	201
K914416	BREATH-EASY, MODIFICATION	Icor AB	1992-06-23	272
K904338	ICOR HCH 4, ICOR HCH 7	Icor AB	1990-12-04	75
K900150	HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE	Icor AB	1990-01-25	14
K895935	ICOR CMU Q PLUS	Icor AB	1990-01-04	85
K883532	ICOR AGENT MONITOR	Icor AB	1988-11-04	78
K881308	BREATH-EASY	Icor AB	1988-05-17	50
K872371	ICOR NEONATAL HCH	Icor AB	1987-09-04	77
K854927	ICOR CALARIC MEASUREMENT UNIT (CMU)	Icor AB	1986-03-27	107

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