Atlas FDA

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

Data Critical Corp. — Predicate Candidate Screening

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

71 daysmedian FDA review time
224 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013156MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEMData Critical Corp.2001-10-19280
K012005MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEMData Critical Corp.2001-07-24270
K011999MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEMData Critical Corp.2001-07-24270
K010912ALARMVIEW WIRELESS DATA NETWORK SYSTEMData Critical Corp.2001-04-0590
K003998FLEXVIEW CLINICAL MONITORING SYSTEMData Critical Corp.2001-03-07710
K992848ALARMVIEW SYSTEMData Critical Corp.1999-11-19870
K990378STATVIEW SYSTEMData Critical Corp.1999-09-202240
K973527CARDIO-PAGER SYSTEMData Critical Corp.1998-03-311940
K971650RHYTHMSTAT XLData Critical Corp.1997-12-042120

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