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

Avl Scientific Corp. — Predicate Candidate Screening

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

56 daysmedian FDA review time

124 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K001632	OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009	Avl Scientific Corp.	2000-06-19	24	0
K000103	AVL OPTI R ANALYZER	Avl Scientific Corp.	2000-03-20	67	0
K993837	AVL OPTI CRITICAL CARE ANALYZER	Avl Scientific Corp.	1999-12-16	34	0
K990092	AVL OMNI MODULAR ANALYZER	Avl Scientific Corp.	1999-01-29	18	4
K984299	AVL OPTI CRITICAL CARE ANALYZER	Avl Scientific Corp.	1998-12-11	10	0
K974784	AVL OPTI CRITICAL CARE ANALYZER	Avl Scientific Corp.	1998-02-24	64	0
K974822	AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL	Avl Scientific Corp.	1998-01-22	29	0
K972733	AVL OMNI ANALYZER	Avl Scientific Corp.	1997-09-09	50	6
K972673	AVL 9181 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1997-08-20	35	7
K963964	AVL COMPACT 3 PH/BLOOD GAS ANALYZER	Avl Scientific Corp.	1996-11-29	58	0
K961458	AVL 9180 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1996-06-12	58	1
K961161	AVL OPTI 1 PH/BLOOD GAS ANALYZER	Avl Scientific Corp.	1996-04-26	35	0
K954018	AVL OMNI ANALYZER	Avl Scientific Corp.	1995-10-05	41	8
K945915	AVL OMNI ANALYZER	Avl Scientific Corp.	1995-04-05	124	9
K944089	AVL OPTI PH/BLOOD GAS ANALYZER	Avl Scientific Corp.	1994-10-20	59	0
K943702	AVL 988-4 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1994-09-09	42	0
K943570	AVL COMPACT 1 PH/BLOOD GAS ANALYZER	Avl Scientific Corp.	1994-08-24	33	0
K942616	AVL COMPACT 2 PH/BLOOD GAS ANALYZER	Avl Scientific Corp.	1994-07-28	56	0
K932642	AVL 9110PH ANALYZER	Avl Scientific Corp.	1993-10-14	134	7
K895317	AVL MODEL 995HB PH/BLOOD GAS ANALYZER	Avl Scientific Corp.	1990-02-01	156	0
K895466	AVL MODEL 912 CO-OXYLITE	Avl Scientific Corp.	1989-11-06	56	0
K891578	AVL MODEL 987 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1989-05-22	63	0
K882154	HEPAX (TENS)	Avl Scientific Corp.	1988-09-30	130	0
K883240	AVL MODEL 986 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1988-09-22	52	0
K870657	AVL MODEL 985 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1987-05-12	83	0
K863333	AVL ISE-TROL ELECTROLYTE CONTROL	Avl Scientific Corp.	1986-09-29	32	0
K862819	AVL MODEL 984 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1986-08-29	36	0
K861087	AVL MODEL 983 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1986-04-07	17	0
K844587	AVL MODEL 982 ELECTROLYTE ANALYZER	Avl Scientific Corp.	1985-01-18	56	0
K834601	AVL MODEL 945 BLOOD GAS SYSTEM	Avl Scientific Corp.	1984-03-09	70	0
K831379	MODEL 947 VIDEO BLOOD GAS SYS	Avl Scientific Corp.	1983-07-28	91	0
K831395	AVL 0073 MICROSAMPLER	Avl Scientific Corp.	1983-07-26	88	0
K821885	REF. ELECTRODE SOL'N.;STANDARD B	Avl Scientific Corp.	1982-07-13	18	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