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

Miles, Inc. — Predicate Candidate Screening

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

80 daysmedian FDA review time

257 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K950292	FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIA	Miles, Inc.	1995-05-02	97
K950353	TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM	Miles, Inc.	1995-04-20	80
K950186	CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO D	Miles, Inc.	1995-03-13	55
K945655	CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (I	Miles, Inc.	1995-01-05	49
K941171	TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)	Miles, Inc.	1994-12-14	275
K943376	OPERA SYSTEM	Miles, Inc.	1994-09-14	63
K941156	TECHNISON AXON SYSTEM	Miles, Inc.	1994-04-26	47
K933682	DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS	Miles, Inc.	1994-04-12	257
K935287	IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM	Miles, Inc.	1994-01-03	61
K933478	TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS	Miles, Inc.	1993-11-22	129
K933475	TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS	Miles, Inc.	1993-11-22	129

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