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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Norfolk Scientific, Inc. · Predicate Candidate Screening

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

25 daysmedian FDA review time
47 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERNorfolk Scientific, Inc.1990-06-20470
K890669STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBENorfolk Scientific, Inc.1989-03-08270
K883185SAFECRIT PLASTIC MICROHEMATOCRIT TUBESNorfolk Scientific, Inc.1988-08-18210
K881254STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01Norfolk Scientific, Inc.1988-04-05130
K870511CHART-TYPE MICRO HEMATOCRIT TUBE READERNorfolk Scientific, Inc.1987-03-16390
K864974GENERAL PURPOSE CENTRIFUGENorfolk Scientific, Inc.1987-01-09210
K860172QWIKSPIN (TM)Norfolk Scientific, Inc.1986-02-11250

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