Atlas FDA

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

Iso-Data, Inc. — Predicate Candidate Screening

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

38 daysmedian FDA review time
60 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K872430ISO-DATA 500 SERIES GAMMA COUNTERIso-Data, Inc.1987-08-21600
K872429ISO-DATA 100 SERIES GAMMA COUNTERIso-Data, Inc.1987-08-21600
K843434ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.Iso-Data, Inc.1984-10-05310
K843365ISO-DATA IMMUNOASSAY NETWORK SYSTEMIso-Data, Inc.1984-09-27300
K810631DPM CALCULATORIso-Data, Inc.1981-03-27170
K780813IDI GDR DATA REDUCTION SYSTEMIso-Data, Inc.1978-06-28440
K780790IDI 200 GAMMA COUNTERIso-Data, Inc.1978-06-22380

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