510(k) Report

FDA applicant

Yellow Springs Instrument Co., Inc.

Yellow Springs, OH23 decisions1978–19962 recalls

FDA records 23 decisions for Yellow Springs Instrument Co., Inc. (Yellow Springs, OH) from 1978 to 1996: 23 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and CGA (Glucose Oxidase, Glucose). 2 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, general hospital panel, where it files most

How often FDA has decided Yellow Springs Instrument Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Yellow Springs Instrument Co., Inc. since 2007.

Recalls per year

1in 2022

2017: 12022: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Yellow Springs Instrument Co., 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?

  • FLLContinuous Measurement Thermometer10decisions
  • CGAGlucose Oxidase, Glucose3decisions
  • BZTStethoscope, Esophageal, With Electrical Conductors2decisions
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase2decisions
  • KHPAcid, Lactic, Enzymatic Method2decisions
  • FMTWarmer, Infant Radiant1decision

Also: HHP (1), EZL (1), CHH (1).

Who builds on its devices?

Later devices cite its devices 6 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.

  • K891480Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerYellow Springs Instrument Co., Inc. · 19893cite it
  • K962070Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 19962cite it
  • K910718Ysi Precision 4000 ThermometerYellow Springs Instrument Co., Inc. · 19911cites it

What has FDA decided for it lately?

  • K962070Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 19962 recalls
  • K922821Ysi Models 4700 Foley Catheter Temperature ProbesYellow Springs Instrument Co., Inc. · 1992
  • K922007Ysi Model 441A Airway Temperature ProbeYellow Springs Instrument Co., Inc. · 1992
  • K910633Ysi Model 1500 Blood Glucose AnalyzerYellow Springs Instrument Co., Inc. · 1991
  • K910718Ysi Precision 4000 ThermometerYellow Springs Instrument Co., Inc. · 1991
  • K901131Ysi Model 1500 Sport L-Lactate AnalyzerYellow Springs Instrument Co., Inc. · 1990
  • K893409Ysi Models 4400 & 4700 Esophageal Stethoscope TempYellow Springs Instrument Co., Inc. · 1989
  • K891480Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerYellow Springs Instrument Co., Inc. · 1989

All 23 as Yellow Springs Instrument Co., Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K962070The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the…Feb 7, 2022Class II
  • K962070Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as…Mar 13, 2017Class II