Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LCR — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
101 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060998 | QMS TOBRAMYCIN | Seradyn, Inc. | 2006-07-21 | 101 | 0 |
| K974029 | ACS TOBRAMYCIN | Chiron Diagnostics Corp. | 1998-02-12 | 112 | 0 |
| K962818 | TOBRAMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | 56 | 0 |
| K952568 | BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT | Beckman Instruments, Inc. | 1995-08-08 | 64 | 0 |
| K911940 | OPUS(R) TOBRAMYCIN | Pb Diagnostic Systems, Inc. | 1991-07-01 | 61 | 0 |
| K911613 | VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 | Exmoor Plastics , Ltd. | 1991-06-28 | 86 | 0 |
| K854873 | INTRAOCULAR PRESSURE REDUCER | Mira, Inc. | 1986-02-04 | 62 | 0 |
| K850058 | DU PONT TOBRAMYCIN ASSAY REAGENTS | E.I. Dupont DE Nemours & Co., Inc. | 1985-01-18 | 10 | 0 |
| K840847 | IMMPULSE TOBRAMYCIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-04 | 40 | 0 |
| K832408 | STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM | American Dade | 1983-08-26 | 36 | 0 |
| K822197 | NEEDLE HOLDERS | Kelleher Corp. | 1982-08-16 | 24 | 0 |
| K821542 | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 | 10 | 0 |
| K820130 | ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY | Syva Co. | 1982-02-05 | 18 | 0 |
| K813542 | TOBRAMYCIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-01-12 | 22 | 0 |
| K810941 | AMES TDA TOBRAMYCIN TEST | Miles Laboratories, Inc. | 1981-04-17 | 10 | 0 |
| K802668 | CYBREX TOBRAMYCIN | Abbott Laboratories | 1980-11-24 | 28 | 0 |
| K801308 | FIAX TEST KIT FOR TOBRAMYCIN QUANTITA | Intl. Diagnostic Technology | 1980-06-20 | 17 | 0 |
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