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

United Diagnostics, Inc. — Predicate Candidate Screening

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

49 daysmedian FDA review time
79 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884977GAS TRAK PLUSUnited Diagnostics, Inc.1989-01-27580
K862278GAS-TRAKUnited Diagnostics, Inc.1986-08-04490
K844018GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3United Diagnostics, Inc.1984-11-27470
K843986STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3United Diagnostics, Inc.1984-11-27470
K831389STAT-TRAK LIQUID ELECTROLYTE CONTROLUnited Diagnostics, Inc.1983-08-101030
K831813CO-OXIMETER CONTROLUnited Diagnostics, Inc.1983-07-28520
K831814CALIBRATION STANDARD-HEMOGLOBINUnited Diagnostics, Inc.1983-07-28520
K831075BLOOD GAS & FLAME PHOTOMETER INSTRU-United Diagnostics, Inc.1983-06-22790
K820705GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROLUnited Diagnostics, Inc.1982-04-01160
K813517BLOOD GAS ANALYSIS, STANDARDS CONTROLSUnited Diagnostics, Inc.1981-12-31150
K810618AMPULED FLAME PHOTOMETER STANDARDSUnited Diagnostics, Inc.1981-03-31220
K792098GAS-TRAK BLOOD GAS CONTROLUnited Diagnostics, Inc.1979-11-13250

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