Atlas FDA

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

FIZ — Predicate Candidate Screening

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

65 daysmedian FDA review time
192 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201765SmartHDM-510 SystemMesa Laboratories, Inc.2020-09-02650
K150657Phoenix XL Dialysate MeterMesa Laboratories, Inc.2015-09-211920
K05081290XL INSTRUMENTATION SYSTEMMesa Laboratories, Inc.2005-05-05350
K020908HDM97Ibp Instruments GmbH2002-05-22630
K020909HDM99Ibp Instruments GmbH2002-05-22630
K992431NEO-2 METERAutomata Instrumentation, Inc.1999-10-13840
K981294ODYSSEY INSTRUMENTATION SYSTEMAutomata Instrumentation, Inc.1998-07-08900
K955298PHOENIX DIALYSATE METERAutomata Medical Instrumentation, Inc.1996-02-291010
K920810NEO-STAT DIALYSATE METERAutomata Medical Instrumentation, Inc.1993-01-153290
K881098MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METERAutomata, Inc.1988-04-21370
K871708NEO-I TEMPERATURE & CONDUCTIVITY METERAutomata, Inc.1987-06-17470
K853735COLORADO MEDICAL MODEL CTM-3000Colorado Medical, Inc.1985-10-04280
K780932MODEL 80 CONDUCTIVITY/TEMP.TEST UNITWestern Laboratories Corp.1978-08-31860

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