Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

IEO — Predicate Candidate Screening

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

62 daysmedian FDA review time
109 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K924590MICROWAVE AUTOMATED TISSUE PROCESSORInnovative Medical Systems, Inc.1992-12-291100
K883599LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)Innovative Medical Systems, Inc.1988-09-02100
K881165SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSORSakura Finetek U.S.A., Inc.1988-07-011030
K853938LX 300 TISSUE PROCESSORInnovative Medical Systems, Inc.1985-10-10160
K851054LX120 TISSUE PROCESSORInnovative Medical Systems, Inc.1985-05-15620
K843506LKB 2189 ULTROPROCESSORLkb Instruments, Inc.1984-11-30850
K834599AUTOTECHNICON V TISSUE PROCESS SYSTechnicon Instruments Corp.1984-02-04360
K831313TISSUE-TEK V.I.P. 100/200Miles Laboratories, Inc.1983-07-28970
K801427TISSUE-TEK III MINI-RAPID PROCESSORMiles Laboratories, Inc.1980-07-28410
K801513TISSUE PROCESSING SYSTEMInnovative Medical Systems, Inc.1980-07-28280
K771308TISSUE-TEK III V.I.P.Miles Laboratories, Inc.1977-08-22350
K761062HISTO-TEK W/ AUTOMATIC COVERSLIPPERMiles Laboratories, Inc.1977-03-071090

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