Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DIH — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
387 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103373 | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 | Beckman Coulter, Inc. | 2011-02-07 | 82 | 0 |
| K061093 | CHOLINESTERASE GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2006-07-03 | 75 | 0 |
| K051444 | SENTINEL CHOLINESTERASE LIQUID | Sentinel Ch. Srl | 2005-06-20 | 18 | 0 |
| K030045 | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) | Olympus America, Inc. | 2003-02-21 | 46 | 0 |
| K023992 | WIENER LAB COLINESTERASA AA | Wiener Laboratories Saic | 2003-02-12 | 72 | 0 |
| K013750 | ADVIA 1650 CHOLINESTERASE ASSAY | Bayer Diagnostics Corp. | 2002-01-18 | 66 | 0 |
| K002792 | CARESIDE CHOLINESTERASE | Careside, Inc. | 2000-11-08 | 62 | 0 |
| K001344 | ADVIA IMS | Bayer Corp. | 2000-06-26 | 60 | 0 |
| K961656 | TEST-MATE CHE CHOLINESTERASE TEST SYSTEM | Eqm Research, Inc. | 1996-11-26 | 210 | 0 |
| K943367 | IL TEST CHOLINESTERASE | Instrumentation Laboratory CO | 1996-02-05 | 572 | 0 |
| K955498 | CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 | Diagnostic Chemicals , Ltd. | 1996-01-24 | 54 | 0 |
| K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE | Tech Intl. Co. | 1991-12-18 | 92 | 0 |
| K913198 | KODAK EKTACHEM DT SLIDES (CHE) | Eastman Kodak Company | 1991-08-26 | 39 | 0 |
| K912148 | CHOLINESTERASE TEST KIT | Crestat Diagnostics, Inc. | 1991-08-12 | 89 | 0 |
| K912217 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | 1991-07-01 | 42 | 0 |
| K893583 | BECKMAN CHOLINESTERASE REAGENT KIT | Beckman | 1989-08-15 | 98 | 0 |
| K885272 | CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE | Sigma Chemical Co. | 1989-03-28 | 96 | 0 |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Sclavo, Inc. | 1989-01-27 | 380 | 0 |
| K873496 | ATYPICAL CHOLINESTERASE | Sclavo, Inc. | 1989-01-27 | 528 | 0 |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Sclavo, Inc. | 1989-01-27 | 387 | 0 |
| K883890 | DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1988-11-29 | 76 | 0 |
| K863203 | CHOLINESTERASE (BTC) REAGENT | Sigma Diagnostics, Inc. | 1986-09-17 | 29 | 0 |
| K863202 | CHOLINESTERASE (PTC) REAGENT | Sigma Diagnostics, Inc. | 1986-09-16 | 28 | 0 |
| K863111 | CHOLINESTERASE | J. D. Assoc. | 1986-09-11 | 29 | 0 |
| K862168 | RAICHEM CHOLINESTERASE REAGENT | Reagents Applications, Inc. | 1986-06-27 | 18 | 0 |
| K791725 | CHOLINESTERASE REAGENT | Gilford Diagnostics | 1979-10-17 | 47 | 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