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

Respiratory Care, Inc. · Predicate Candidate Screening

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

28 daysmedian FDA review time

83 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K892230	RCI VIRAL/BACTERIAL FILTER	Respiratory Care, Inc.	1989-08-28	146	0
K884150	MODIFIED CONCHATHERM III CONTROLLED HEATER	Respiratory Care, Inc.	1988-11-21	49	0
K881625	CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL	Respiratory Care, Inc.	1988-06-21	70	0
K864147	AQUAVALVE	Respiratory Care, Inc.	1986-12-05	44	0
K863955	COLBY LEVEL ALARM	Respiratory Care, Inc.	1986-11-07	28	0
K861555	CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT	Respiratory Care, Inc.	1986-06-05	41	0
K834151	CONCHATHERM LHF HUMIDIFIER HEATER	Respiratory Care, Inc.	1984-01-13	43	0
K833974	AQUAPAK 020 HUMIDIFIER ADAPTER	Respiratory Care, Inc.	1983-12-16	30	30
K832453	SLIMB SINGLE LIMB BREATHING CIRCUIT	Respiratory Care, Inc.	1983-10-27	93	0
K811524	AQUACADE	Respiratory Care, Inc.	1981-07-01	33	0
K811073	A QUAPAK	Respiratory Care, Inc.	1981-04-29	9	0
K800635	C.C.-PAK	Respiratory Care, Inc.	1980-04-10	20	0
K792268	CIRCAPAK	Respiratory Care, Inc.	1979-11-27	18	0
K780845	CONCHANEOPAK A CARTRIDGE HUMIDIFIER	Respiratory Care, Inc.	1978-08-14	83	0
K780580	TEMPERATURE INDICATOR	Respiratory Care, Inc.	1978-04-27	17	0
K780562	AQUAPAK PREFILLED HUMIDIFIER	Respiratory Care, Inc.	1978-04-27	20	0
K780011	CONCHAPAK OXYGEN DILUTER	Respiratory Care, Inc.	1978-02-02	30	0
K780044	BREATHING CIRCUIT, BAIN	Respiratory Care, Inc.	1978-02-02	24	0
K772348	NEBULIZER ADAPTER	Respiratory Care, Inc.	1978-01-03	11	1
K771975	ARTERIAL BLOOD SAMPLING TRAY	Respiratory Care, Inc.	1977-10-28	11	0
K771307	BAIN BREATHING CIRCUIT	Respiratory Care, Inc.	1977-08-04	17	0
K761202	AQUA-SEAL	Respiratory Care, Inc.	1976-12-09	2	0
K760964	ADDI-MIST	Respiratory Care, Inc.	1976-12-09	35	0
K760866	CONCHA-COLUMN	Respiratory Care, Inc.	1976-11-01	14	0
K760683	ALARM, THERMAL, THERM-ALERT	Respiratory Care, Inc.	1976-09-27	7	0
K760335	NEBULIZER, MICRO (ADDI-MIST)	Respiratory Care, Inc.	1976-08-11	13	0

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