510(k) Report

FDA applicant

Beckman Instruments, Inc.

Mchenry, IL281 decisions1976–199855 recalls

FDA records 281 decisions for Beckman Instruments, Inc. (Mchenry, IL) from 1976 to 1998: 281 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJE (Analyzer, Chemistry (Photometric, Discrete)…). Its devices cite 83 predicates, 53 of them its own earlier devices. 55 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Beckman Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Beckman Instruments, Inc. since 2007.

Recalls per year

1in 2024

2007: 12009: 42010: 212011: 52012: 12017: 22019: 42021: 12024: 1
2007high 21 (2010) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Beckman Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Beckman Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)10decisions
  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use9decisions
  • JIXCalibrator, Multi-Analyte Mixture8decisions
  • JJTEnzyme Controls (Assayed And Unassayed)7decisions
  • CHHEnzymatic Esterase--Oxidase, Cholesterol7decisions
  • JJJCounter (Beta, Gamma) For Clinical Use7decisions

Also: JJX (6), CKA (4), CDT (4), CFJ (4), DCK (4), MSJ (4).

Whose devices does it build on?

Its devices cite 83 predicates; 53 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 122 times; 53 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K922273Array (R) 360Beckman Instruments, Inc. · 19928cite it
  • K780913Additional Reagents Kits for Imm. SystemBeckman Instruments, Inc. · 19787cite it
  • K771603Immochemistry SystemBeckman Instruments, Inc. · 19777cite it
  • K965240Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric…Beckman Instruments, Inc. · 19975cite it
  • K926272Beckman Transferrin KitBeckman Instruments, Inc. · 19934cite it
  • K864236Synchron CX3Beckman Instruments, Inc. · 19864cite it

What has FDA decided for it lately?

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall
  • K974816Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225, 33229Beckman Instruments, Inc. · 1998
  • K974564Immage Immunochemistry System Alpha-2-Macroglobulin ReagentBeckman Instruments, Inc. · 1998
  • K974110Immage Immunochemistry System Antithrombin Iii (AT3) ReagentBeckman Instruments, Inc. · 1997

All 281 as Beckman Instruments, Inc. →

What has been recalled?

55 recalls linked to its devices; the latest:

  • K963868IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when…Jul 31, 2024Class II
  • K971505SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825Nov 10, 2021Class II
  • K902801Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300…Aug 15, 2019Class II
  • K944075SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product…Jun 12, 2019Class II
  • K973966Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830…Apr 30, 2019Class II
  • K982250Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880…Apr 30, 2019Class II

Other applicant names beginning “Beckman”

FDA records each applicant name separately; these may or may not be the same firm.

Beckman Coulter, Inc. 286Beckman-Diagnostic Systems Group 11Beckman Coulter Ireland, Inc. 7Beckman 6Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 2Beckman Analytical and Biotechnology Development 1Beckman Coulter Cellular 1Beckman Coulter Biomedical GmbH 1