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

Bionostics, Inc. — Predicate Candidate Screening

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

40 daysmedian FDA review time

92 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K131136	GLUCOSE METER-CHECK SOLUTION FOR TAIDOC	Bionostics, Inc.	2013-05-31	39	0
K123851	GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK	Bionostics, Inc.	2013-02-14	62	0
K123966	GLUCOSE METER-CHECK SOLUTION FOR BAYER	Bionostics, Inc.	2013-01-25	30	0
K113764	GLUCOSE METER-CHECK SOLUTION FOR INFOPIA	Bionostics, Inc.	2012-01-30	40	0
K112352	GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT	Bionostics, Inc.	2011-12-23	129	0
K112356	GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE	Bionostics, Inc.	2011-09-19	34	0
K103553	LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLU	Bionostics, Inc.	2011-02-10	69	0
K101831	ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800	Bionostics, Inc.	2010-10-01	92	0
K091914	OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION	Bionostics, Inc.	2009-11-06	129	0
K081478	RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CO	Bionostics, Inc.	2008-10-06	132	0
K082395	GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOO	Bionostics, Inc.	2008-09-18	30	0
K081403	GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK	Bionostics, Inc.	2008-07-25	67	0
K063398	ESA LEADCARE II LEAD CONTROL	Bionostics, Inc.	2006-12-05	26	0
K053327	OXICOM CONTROL	Bionostics, Inc.	2006-01-26	56	0
K050961	RNA1C CONTROL FOR NYCOCARD HBA1C	Bionostics, Inc.	2005-05-13	25	0
K050100	RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+	Bionostics, Inc.	2005-02-25	38	0
K032819	GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOST	Bionostics, Inc.	2003-10-20	40	0
K032453	ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL	Bionostics, Inc.	2003-08-28	17	0
K022769	LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION	Bionostics, Inc.	2002-11-13	84	0
K021697	GLUCOSE CONTROL SOLUTION FOR BD LATITUDE	Bionostics, Inc.	2002-07-12	51	0
K021624	RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA	Bionostics, Inc.	2002-07-12	57	0
K021930	MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL	Bionostics, Inc.	2002-06-25	13	0
K021924	MEDICA EASYQC HEMATOCRIT CONTROL	Bionostics, Inc.	2002-06-24	13	0
K013147	GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE	Bionostics, Inc.	2001-10-24	34	1
K012431	COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL T	Bionostics, Inc.	2001-08-28	28	0
K012430	MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL	Bionostics, Inc.	2001-08-27	27	0
K002540	BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MED	Bionostics, Inc.	2000-09-18	33	0
K000318	BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE	Bionostics, Inc.	2000-02-28	27	0
K980178	OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY	Bionostics, Inc.	1998-02-12	23	0
K972868	TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CR	Bionostics, Inc.	1997-08-28	24	2
K955630	RNA MEDICAL HEMAT CONTROL	Bionostics, Inc.	1996-03-01	81	0
K950399	RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL	Bionostics, Inc.	1995-02-22	21	0
K943754	BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CON	Bionostics, Inc.	1994-09-14	43	0
K922357	RNA MEDICAL'S EQUIL 55	Bionostics, Inc.	1992-06-30	42	0
K922386	RNA MEDICAL TONOMETER	Bionostics, Inc.	1992-06-26	37	0
K913133	CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)	Bionostics, Inc.	1991-09-27	73	0
K911755	CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE	Bionostics, Inc.	1991-05-22	34	0
K904698	SECONDARY CALIBRATORS	Bionostics, Inc.	1990-11-28	43	0
K904335	SECONDARY CALIBRATORS	Bionostics, Inc.	1990-10-12	22	0
K880447	MULTI-FUNCTION BLOOD GAS CONTROL	Bionostics, Inc.	1988-05-27	115	0
K880710	PROTEIN BASE ISE CONTROL	Bionostics, Inc.	1988-03-24	31	0
K874408	MULTI-FUNCTION BLOOD GAS CONTROL	Bionostics, Inc.	1987-12-14	47	0
K851911	MULTI FUNCTION BLOOD GAS CONTROL	Bionostics, Inc.	1985-05-20	19	0
K841783	BLOOD GAS CONTROL, LEVEL I(ACIDOSIS	Bionostics, Inc.	1984-06-14	45	0
K840843	POTASSIUM CHLORIDE TABLETS	Bionostics, Inc.	1984-04-17	53	0
K840299	PH ELECTRODE CALIBRATING BUFFERS-BLOOD	Bionostics, Inc.	1984-03-23	59	0
K840300	FLUSH SOLUTION CONCENTRATE-BLOOD GAS	Bionostics, Inc.	1984-03-23	59	0
K833146	AQUEOUS BLOOD GAS CONTROL	Bionostics, Inc.	1983-11-28	74	0
K831872	CALIBRATOR 282	Bionostics, Inc.	1983-07-18	35	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