Atlas FDA

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

Radiation Technology, Inc. — Predicate Candidate Screening

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

24 daysmedian FDA review time
158 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K910648THERAPY CHAIR SYSTEMRadiation Technology, Inc.1991-07-221580
K802892CULTURE MEDIA FOR IN VITRO DIAG. USERadiation Technology, Inc.1980-12-11240
K801943BRAIN HEART INFUSION MICROBIOLOGICALRadiation Technology, Inc.1980-09-09260
K801817MICROBIOLOGY CULTURE MEDIA, C.L.E.D.Radiation Technology, Inc.1980-08-27270
K801901MUELLER HINTON AGARRadiation Technology, Inc.1980-08-20120
K801772MICROBIOLOGY CULTURE MEDIA-MACCONKEY AGRadiation Technology, Inc.1980-08-20230
K801847TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIARadiation Technology, Inc.1980-08-1390

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