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

LTT — Predicate Candidate Screening

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

77 daysmedian FDA review time

209 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243804	MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime	Beckman Coulter, Inc.	2025-08-20	252	0
K250036	MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomyc	Beckman Coulter, Inc.	2025-08-15	219	0
K250084	MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreona	Beckman Coulter, Inc.	2025-07-18	186	0
K202343	MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazid	Beckman Coulter, Inc.	2020-11-16	90	1
K201423	MicroScan Dried Gram-Negative MIC/Combo Panels with Meropene	Beckman Coulter, Inc.	2020-06-29	31	0
K193536	MicroScan Dried Gram Negative MIC/Combo Panels with Ciproflo	Beckman Coulter, Inc.	2020-03-18	89	0
K193358	MicroScan Dried Gram-Negative MIC/Combo Panels with Levoflox	Beckman Coulter, Inc.	2020-03-03	90	0
K183127	MicroScan Dried Gram Negative MIC/Combo Panels with Meropene	Beckman Coulter, Inc.	2019-02-12	91	0
K172337	MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazid	Beckman Coulter, Inc.	2017-12-15	135	0
K172912	MicroScan Dried Gram-Negative MIC/Combo Panels with Ciproflo	Beckman Coulter, Inc.	2017-12-07	73	0
K172255	MicroScan Dried Gram Negative MIC/Combo Panels with Ceftoloz	Beckman Coulter, Inc.	2017-12-01	128	0
K162740	MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem	Beckman Coulter, Inc.	2017-03-21	172	0
K150039	MicroScan Dried Gram Positive MIC/Combo Panels with vancomyc	Siemens Healthcare Diagnostics, Inc.	2015-07-02	174	0
K131275	MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS	Siemens Helathcare Diagnostics, Inc.	2013-11-08	189	0
K123933	MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE	Siemens Healthcare Diagnostics, Inc.	2013-03-14	84	0
K111394	MICROSCAN MICROSTEP	Siemens Healthcare Diagnostics, Inc.	2011-06-22	35	0
K091949	MICROSCAN MICROSTREP PLUS, MODEL B1027-201	Siemens Healthcare Diagnostics	2010-01-26	209	3
K091264	MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017	Siemens Healthcare Diagnostics	2009-07-22	83	0
K083262	MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYC	Siemens Healthcare Diagnostics	2009-02-18	105	0
K062773	MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN	Dade Behring, Inc.	2006-10-13	25	2
K062777	MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN	Dade Behring, Inc.	2006-10-10	22	0
K033940	MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/C	Dade Behring, Inc.	2004-02-25	68	0
K030620	PASCO MIC AND MIC/ID PANELS	Pasco Laboratories, Inc.	2003-04-14	46	0
K024357	SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES	Trek Diagnostic Systems, Inc.	2003-03-17	77	0
K024353	SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES	Trek Diagnostic Systems, Inc.	2003-03-06	66	0
K021184	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCI	Dade Microscan, Inc.	2002-06-20	66	0
K021078	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYC	Dade Microscan, Inc.	2002-06-06	64	0
K021111	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXI	Dade Microscan, Inc.	2002-06-06	62	0
K020939	MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE	Dade Microscan, Inc.	2002-05-17	56	0
K020627	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXAC	Dade Microscan, Inc.	2002-05-06	69	0
K020626	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN	Dade Microscan, Inc.	2002-04-26	59	2
K020160	DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN	Dade Behring, Inc.	2002-03-14	56	0
K013368	HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE	Trek Diagnostic Systems, Inc.	2001-11-20	40	0
K013195	HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY	Trek Diagnostic Systems, Inc.	2001-11-07	43	0
K010418	DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS	Dade Behring, Inc.	2001-08-22	191	0
K010159	DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	2001-07-27	191	0
K011116	PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY T	Pasco Laboratories, Inc.	2001-04-24	62	0
K010508	PASCO MIC AND MIC/ID PANELS	Pasco Laboratories, Inc.	2001-04-23	61	8
K003619	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	2001-01-09	48	0
K001721	PASCO MIC AND MIC/ID PANELS	Pasco Laboratories, Inc.	2000-08-04	59	0
K993102	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1999-12-02	77	0
K983306	SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXAC	Accumed Intl., Inc.	1998-12-18	88	0
K983309	SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXA	Accumed Intl., Inc.	1998-12-14	84	0
K973317	PASCO MIC AND MIC/ID PANELS	Pasco Laboratories, Inc.	1997-11-14	72	0
K972799	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1997-10-10	74	0
K962150	DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS	Dade Intl., Inc.	1996-08-16	73	0
K960366	SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES	Accumed Intl., Inc.	1996-04-09	75	0
K935704	DRIED GRAM-NEGATIVE MIC//COMBO PANELS	Baxter Diagnostics, Inc.	1995-04-14	500	0
K945235	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Baxter Diagnostics, Inc.	1995-03-07	131	0
K941030	DRIED GRAM-NEGATIVE CEFPODOXIME	Baxter Diagnostics, Inc.	1995-02-16	349	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