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Ackrad Laboratories — Predicate Candidate Screening

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

51 daysmedian FDA review time

106 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021272	SIB CATHETER, MODEL 61-7005	Ackrad Laboratories	2002-05-21	29	0
K020954	H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPT	Ackrad Laboratories	2002-04-24	30	0
K020951	H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F),	Ackrad Laboratories	2002-04-16	22	1
K970492	INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER	Ackrad Laboratories	1997-04-09	58	1
K961752	H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)	Ackrad Laboratories	1996-08-08	94	2
K940176	ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION	Ackrad Laboratories	1996-04-23	833	0
K952542	ACKRAD ESOPHAGEAL BALLOON CATHETER SET	Ackrad Laboratories	1996-04-23	336	0
K953034	H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)	Ackrad Laboratories	1995-08-29	71	0
K915813	ACKRAD ERCP CONTRAST DELIVERY SET	Ackrad Laboratories	1992-03-11	72	0
K904499	NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)	Ackrad Laboratories	1991-07-01	273	0
K911780	INFANT NASAL CANNULAE ASSEMBLY, MODIFIED	Ackrad Laboratories	1991-06-24	63	0
K901574	ACKRAD MPR DRAINAGE CATHETER SET	Ackrad Laboratories	1990-06-29	87	0
K895031	MODIFIED INFANT NASAL CANNULAE ASSEMBLY	Ackrad Laboratories	1989-10-30	83	0
K881680	ACKRAD H/S PROCEDURE TRAY	Ackrad Laboratories	1988-07-15	87	0
K880161	ACKRAD PEDIATRIC C.P.A.P. SYSTEM	Ackrad Laboratories	1988-03-04	51	0
K874293	ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET	Ackrad Laboratories	1987-12-29	70	0
K874312	ACKRAD RETROGRADE URETHROGRAPHY SET	Ackrad Laboratories	1987-12-29	70	0
K872277	TRAKEFIT TRACHEOSTOMY TUBE HOLDER	Ackrad Laboratories	1987-07-21	36	0
K864818	ACKRAD TDI SET	Ackrad Laboratories	1987-04-09	121	0
K871069	MODIFIED HYSTEROSALPINGOGRAPY SET	Ackrad Laboratories	1987-04-06	19	0
K865108	N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE	Ackrad Laboratories	1987-02-10	41	0
K854320	ACKRAD ORAL SUCTION TUBE	Ackrad Laboratories	1986-01-10	74	0
K852154	ACKRAD SIALOGRAPHY CATHETER	Ackrad Laboratories	1985-06-26	40	0
K850784	BRONCHITRAC L	Ackrad Laboratories	1985-03-25	27	0
K850309	COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK	Ackrad Laboratories	1985-02-14	20	0
K844557	ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE	Ackrad Laboratories	1984-12-17	26	0
K842231	ACKRAD HYSTEROSALPINGOGRAPHY SET	Ackrad Laboratories	1984-09-19	106	0
K841773	INFANT NASAL CANNULAE ASSEMBLY	Ackrad Laboratories	1984-07-26	87	0
K840490	FLUID REMOVAL ASSEMBLY	Ackrad Laboratories	1984-04-17	71	0
K840056	PEDIATRIC INTUBATION CIRCUIT	Ackrad Laboratories	1984-02-10	35	0
K834089	COMFIT	Ackrad Laboratories	1983-12-29	31	0
K833633	BRONCHITRAC DF DUAL RESP/CATHETER	Ackrad Laboratories	1983-12-08	52	0
K823936	CPAP INFANT NASAL CANNULAE SET	Ackrad Laboratories	1983-01-28	30	0
K822398	ACKRAD BRONCHITRAC	Ackrad Laboratories	1982-10-04	55	0
K822228	GASTRO VAGE SET FOR GASTRIC LAVAGE	Ackrad Laboratories	1982-09-09	44	0
K820937	ACKRAD FLUID CONNECTING SET	Ackrad Laboratories	1982-04-26	21	0
K813607	ACKRAD N-DO VAGE TUBE	Ackrad Laboratories	1982-02-05	38	0
K813103	ACKRAD INCISION & DRAIN SET	Ackrad Laboratories	1981-12-09	36	0
K811185	N-D0-SURE	Ackrad Laboratories	1981-06-02	34	0
K810059	ENDO-MED TUBE FOR ENDOTRACHEAL MED	Ackrad Laboratories	1981-02-26	44	0
K810209	IRRIJET	Ackrad Laboratories	1981-02-17	22	0
K790009	ICE PACK, REUSABLE FLEXIBLE	Ackrad Laboratories	1979-01-22	20	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