Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beckman Coulter, Inc. — Predicate Candidate Screening
270 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
263 days90th percentile
270clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252169 | Access BNP II | Beckman Coulter, Inc. | 2026-03-24 | 257 | 0 |
| K254059 | Access anti-HBc IgM | Beckman Coulter, Inc. | 2026-03-13 | 86 | 0 |
| K253687 | Access anti-HBc Total | Beckman Coulter, Inc. | 2026-02-19 | 90 | 0 |
| K251995 | Access anti-HAV IgM | Beckman Coulter, Inc. | 2026-01-27 | 214 | 0 |
| K250588 | Access Rubella IgG | Beckman Coulter, Inc. | 2025-11-17 | 263 | 0 |
| K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025-09-10 | 26 | 0 |
| K243846 | Access anti-HAV | Beckman Coulter, Inc. | 2025-09-09 | 267 | 0 |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime | Beckman Coulter, Inc. | 2025-08-20 | 252 | 0 |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomyc | Beckman Coulter, Inc. | 2025-08-15 | 219 | 0 |
| K243483 | Access hsTnI | Beckman Coulter, Inc. | 2025-08-01 | 266 | 0 |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreona | Beckman Coulter, Inc. | 2025-07-18 | 186 | 0 |
| K242870 | Access hsTnI | Beckman Coulter, Inc. | 2025-06-16 | 266 | 0 |
| K242022 | Access Toxo IgG | Beckman Coulter, Inc. | 2025-03-28 | 260 | 0 |
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025-03-05 | 223 | 2 |
| K242095 | Access Toxo IgM II | Beckman Coulter, Inc. | 2024-10-11 | 86 | 0 |
| K241427 | Access Syphilis | Beckman Coulter, Inc. | 2024-09-06 | 109 | 0 |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024-08-09 | 171 | 0 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH | Beckman Coulter, Inc. | 2024-07-05 | 157 | 2 |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024-07-03 | 83 | 0 |
| K240987 | Access sTfR | Beckman Coulter, Inc. | 2024-07-03 | 84 | 0 |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-28 | 85 | 0 |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-07 | 18 | 0 |
| K240479 | Access OV Monitor | Beckman Coulter, Inc. | 2024-05-10 | 80 | 0 |
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024-05-09 | 90 | 0 |
| K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | 2024-05-03 | 39 | 0 |
| K240182 | Access EPO | Beckman Coulter, Inc. | 2024-04-22 | 90 | 0 |
| K232164 | Access NT-proBNP | Beckman Coulter, Inc. | 2024-04-12 | 266 | 0 |
| K234052 | Access Ferritin | Beckman Coulter, Inc. | 2024-03-20 | 90 | 0 |
| K240273 | Access Free T4 | Beckman Coulter, Inc. | 2024-03-06 | 35 | 0 |
| K232791 | Access Intact PTH | Beckman Coulter, Inc. | 2024-03-01 | 172 | 1 |
| K234005 | Access CK-MB | Beckman Coulter, Inc. | 2024-02-16 | 59 | 0 |
| K233480 | Access SHBG | Beckman Coulter, Inc. | 2024-02-08 | 105 | 0 |
| K222881 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-18 | 452 | 1 |
| K230648 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-04 | 270 | 1 |
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023-11-22 | 86 | 1 |
| K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023-09-26 | 692 | 0 |
| K223921 | Access CEA | Beckman Coulter, Inc. | 2023-09-22 | 267 | 0 |
| K231832 | Access Myoglobin | Beckman Coulter, Inc. | 2023-09-18 | 88 | 0 |
| K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023-09-15 | 529 | 0 |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | 2023-08-23 | 265 | 0 |
| K222996 | Access PCT | Beckman Coulter, Inc. | 2023-04-26 | 210 | 0 |
| K221493 | MicroScan Prompt Inoculation System-D | Beckman Coulter, Inc. | 2023-04-05 | 317 | 0 |
| K223038 | Access Cortisol | Beckman Coulter, Inc. | 2023-02-08 | 132 | 1 |
| K223679 | Access AMH | Beckman Coulter, Inc. | 2023-02-03 | 57 | 0 |
| K223503 | Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 2023-01-19 | 58 | 0 |
| K223405 | Access Testosterone | Beckman Coulter, Inc. | 2023-01-13 | 65 | 1 |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022-12-27 | 174 | 0 |
| K223289 | Access Vitamin B12 | Beckman Coulter, Inc. | 2022-12-23 | 59 | 0 |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analy | Beckman Coulter, Inc. | 2022-11-10 | 196 | 18 |
| K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | 2022-03-23 | 61 | 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