Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Healthcare Diagnostics, Inc. · Predicate Candidate Screening
153 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
346 days90th percentile
153clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 | 88 | 0 |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 | 245 | 0 |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 | 262 | 0 |
| K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 | 222 | 0 |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 | 261 | 0 |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 | 262 | 0 |
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 | 267 | 0 |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 | 89 | 0 |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Choles | Siemens Healthcare Diagnostics, Inc. | 2024-07-26 | 35 | 0 |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 | 90 | 0 |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2024-04-04 | 192 | 0 |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 | 112 | 0 |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. | 2023-09-24 | 601 | 0 |
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (V | Siemens Healthcare Diagnostics, Inc. | 2023-08-08 | 361 | 0 |
| K221605 | Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 | 418 | 0 |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 | 347 | 0 |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormo | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 | 360 | 1 |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 | 255 | 0 |
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Siemens Healthcare Diagnostics, Inc. | 2023-06-02 | 346 | 0 |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 | 245 | 0 |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | 2023-03-17 | 333 | 1 |
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2022-08-26 | 207 | 0 |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | 2021-11-24 | 131 | 0 |
| DEN190056 | ADVIA Centaur Enhanced Liver Fibrosis (ELF) | Siemens Healthcare Diagnostics, Inc. | 2021-08-20 | 603 | 0 |
| K193397 | ADVIA Centaur® Digoxin assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-16 | 588 | 0 |
| K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 | 532 | 0 |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 | 515 | 2 |
| K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | 2020-05-29 | 88 | 0 |
| K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. | 2020-04-06 | 70 | 0 |
| K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020-03-27 | 221 | 2 |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020-02-13 | 58 | 0 |
| K193493 | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 | 29 | 0 |
| K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 | 56 | 0 |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 | 53 | 0 |
| K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 | 30 | 0 |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 | 79 | 0 |
| K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 | 60 | 0 |
| K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), | Siemens Healthcare Diagnostics, Inc. | 2019-07-17 | 33 | 0 |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-05-17 | 63 | 0 |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-03-04 | 200 | 0 |
| K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Cont | Siemens Healthcare Diagnostics, Inc. | 2018-07-30 | 84 | 0 |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | 2018-07-19 | 415 | 0 |
| K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2018-07-16 | 91 | 0 |
| K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 | 203 | 0 |
| K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | 2018-07-12 | 437 | 0 |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | 2018-05-25 | 31 | 0 |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | 2018-04-12 | 265 | 3 |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 | 240 | 0 |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 | 173 | 0 |
| K170293 | Emit II Plus Cocaine Metabolite Assay | Siemens Healthcare Diagnostics, Inc. | 2017-10-25 | 267 | 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