Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JJM — Predicate Candidate Screening

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

72 daysmedian FDA review time
116 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K965036THE ADVANCED OSMOMETER (3900)Advanced Instruments, Inc.1997-02-20650
K962056ADVANCED MICRO-OSMOMETER MODEL 3300Advanced Instruments, Inc.1996-07-11440
K925970MODEL 3D3 OSMOMETERAdvanced Instruments, Inc.1993-07-092260
K911092OSMOMETER MODEL 2400Advanced Instruments, Inc.1991-05-22720
K873642OSMOMETER MODEL 110Advanced Instruments, Inc.1987-10-20410
K843997AO-10 AUTOMATED OSMOMETERbioMerieux, Inc.1984-10-31200
K842750OSMOTIC PRESSURE AUTO & STAT OM-6010Kyoto Diagnostics, Inc.1984-08-17350
K834214WESCOR 5500 VAPOR PRESSURE OSMOMETERWescor, Inc.1984-03-301160
K834208COLLOID OSMOMETER 4400Wescor, Inc.1984-03-231092
K832783MICRO-SAMPLE OSMOMETER 3M0Advanced Instruments, Inc.1983-11-281040
K811179OSMOMETER MODEL OM-6010Fiske Med Science1981-05-15170
K790611OSMOMETER MODEL 3W11Advanced Instruments, Inc.1979-06-15780

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