510(k) Report

FDA applicant

Advanced Instruments, Inc.

Unnamed device16 decisions1979–20161 recall

FDA records 16 decisions for Advanced Instruments, Inc. (Unnamed device) from 1979 to 2016: 16 510(k) clearances. Most are in product codes JJM (Osmometer For Clinical Use) and JOW (Sleeve, Limb, Compressible). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is 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 Advanced Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12012: 12016: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JJMOsmometer For Clinical Use7decisions
  • JOWSleeve, Limb, Compressible1decision
  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use1decision
  • DQAOximeter1decision
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision
  • CIGDiazo Colorimetry, Bilirubin1decision

Also: GKL (1), LMC (1), GWQ (1).

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K930526Intermittent Compression System Model 5000Advanced Instruments, Inc. · 19933cite it
  • K790608BL BilirubinometerAdvanced Instruments, Inc. · 19791cites it

What has FDA decided for it lately?

  • K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc. · 20161 recall
  • K120631Patient MonitorAdvanced Instruments, Inc. · 2012
  • K112465Vital Signs MonitorAdvanced Instruments, Inc. · 2011
  • K965036The Advanced Osmometer (3900)Advanced Instruments, Inc. · 1997
  • K962056Advanced Micro-Osmometer Model 3300Advanced Instruments, Inc. · 1996
  • K930526Intermittent Compression System Model 5000Advanced Instruments, Inc. · 1993
  • K925970Model 3D3 OsmometerAdvanced Instruments, Inc. · 1993
  • K911092Osmometer Model 2400Advanced Instruments, Inc. · 1991

All 16 as Advanced Instruments, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K152776GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is…Feb 7, 2018Class II