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

ACON Laboratories, Inc. — Predicate Candidate Screening

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

79 daysmedian FDA review time

235 days90th percentile

86clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261212	Flowflex Plus RSV + Flu A/B + COVID Rapid Test	ACON Laboratories, Inc.	2026-07-10	87	0
K251697	Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus S	ACON Laboratories, Inc.	2025-11-26	177	0
K251749	Flowflex Plus RSV + Flu A/B + COVID Home Test	ACON Laboratories, Inc.	2025-10-22	138	0
K250085	On Call® Sure GK Blood Glucose & Ketone Monitoring System; O	ACON Laboratories, Inc.	2025-10-10	270	0
K250377	Flowflex Plus COVID-19 + Flu A/B Home Test	ACON Laboratories, Inc.	2025-05-10	89	0
K232715	Distinct® Digital Pregnancy Test	ACON Laboratories, Inc.	2024-05-31	269	0
K233373	Flowflex® Plus COVID-19 Home Test	ACON Laboratories, Inc.	2024-04-19	200	0
K230828	Flowflex COVID-19 Antigen Home Test	ACON Laboratories, Inc.	2023-11-09	227	0
K193318	Distinct® Early Detection Pregnancy Test	ACON Laboratories, Inc.	2020-08-20	262	0
K192175	On Call Express II Blood Glucose Monitoring System	ACON Laboratories, Inc.	2019-10-17	66	0
K191038	On Call Express Voice Blood Glucose Monitoring System	ACON Laboratories, Inc.	2019-06-12	55	0
K181527	On Call Sure Blood Glucose Monitoring System, On Call Sure S	ACON Laboratories, Inc.	2018-10-03	114	0
K180504	Mission Lipid Panel Monitoring System	ACON Laboratories, Inc.	2018-03-28	30	0
K180196	On Call Express Mobile Blood Glucose Monitoring System	ACON Laboratories, Inc.	2018-03-07	42	0
K163406	Mission Cholesterol Monitoring System, Mission Cholesterol P	ACON Laboratories, Inc.	2017-07-11	218	0
K170587	On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ket	ACON Laboratories, Inc.	2017-07-06	128	0
K151595	On Call Express Pro Blood Glucose Monitoring System	ACON Laboratories, Inc.	2015-09-05	85	0
K142543	Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Cont	ACON Laboratories, Inc.	2015-05-11	243	0
K150330	Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)	ACON Laboratories, Inc.	2015-04-30	79	0
K142391	Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagen	ACON Laboratories, Inc.	2014-12-22	117	0
K131469	ACON ON CALL DIABETES MANAGEMENT SOFTWARE	ACON Laboratories, Inc.	2014-01-06	230	0
K130284	ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM	ACON Laboratories, Inc.	2013-12-20	318	0
K132086	ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM	ACON Laboratories, Inc.	2013-12-19	167	0
K122553	MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM	ACON Laboratories, Inc.	2013-08-05	349	0
K123010	ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM	ACON Laboratories, Inc.	2012-12-14	78	0
K122110	ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM	ACON Laboratories, Inc.	2012-11-21	127	0
K113332	ON CALL CHOSEN LANCING DEVICE	ACON Laboratories, Inc.	2012-04-18	156	0
K112653	ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS	ACON Laboratories, Inc.	2012-04-09	210	0
K120124	FORESIGHT U120 URINE ANALYZER	ACON Laboratories, Inc.	2012-03-06	49	0
K111221	MISSION U500 URINE ANALYZER	ACON Laboratories, Inc.	2012-01-18	261	0
K111371	ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM	ACON Laboratories, Inc.	2011-10-06	143	0
K103387	MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE C	ACON Laboratories, Inc.	2011-02-02	76	0
K101371	ON CALL PLUS DIABETES MONITORING SOFTWARE	ACON Laboratories, Inc.	2011-01-07	235	0
K093879	MISSION SALIVA ALCOHOL TEST STRIP	ACON Laboratories, Inc.	2010-08-06	231	0
K093143	MISSION BREATH ALCOHOL DETECTOR	ACON Laboratories, Inc.	2010-01-28	115	1
K063295	ACON UTI URINARY TRACT INFECTION TEST STRIPS	ACON Laboratories, Inc.	2007-10-12	345	0
K070929	ACON U120 URINE ANALYZER, MODEL U111-101	ACON Laboratories, Inc.	2007-07-30	118	0
K063418	ACON DIGITAL THERMOMETER PROBE COVERS	ACON Laboratories, Inc.	2007-02-02	81	0
K060925	ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W	ACON Laboratories, Inc.	2006-05-09	35	0
K060466	ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE	ACON Laboratories, Inc.	2006-04-21	58	0
K060173	ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL TH	ACON Laboratories, Inc.	2006-03-17	53	0
K050936	ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG T	ACON Laboratories, Inc.	2005-06-24	71	0
K050878	ON CALL MULTI-DRUG HOME TEST CUP	ACON Laboratories, Inc.	2005-06-08	63	0
K050546	ACON +/- MIDSTREAM PREGNANCY TEST	ACON Laboratories, Inc.	2005-05-20	79	0
K050593	ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE	ACON Laboratories, Inc.	2005-05-06	59	0
K050050	ON CALL MULTI-DRUG HOME TEST	ACON Laboratories, Inc.	2005-03-11	60	0
K042272	ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASM	ACON Laboratories, Inc.	2005-02-28	189	1
K043507	ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE	ACON Laboratories, Inc.	2005-02-25	67	0
K041822	ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE	ACON Laboratories, Inc.	2004-09-16	72	0
K042151	ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST	ACON Laboratories, Inc.	2004-09-09	31	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