Atlas FDA

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

D.R.G. Scientific Industries · Predicate Candidate Screening

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

55 daysmedian FDA review time
209 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892329OSMOMETER STANDARD SOLUTIONSD.R.G. Scientific Industries1989-10-312090
K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific Industries1987-07-081250
K863825CO-OXIMETER SOLUTIONSD.R.G. Scientific Industries1986-11-24550
K863880BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.D.R.G. Scientific Industries1986-11-24490
K863824SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.D.R.G. Scientific Industries1986-10-24240

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