510(k) Report

FDA applicant

Biomedix, Inc.

Spencer, IN11 decisions1993–20141 recall

FDA records 11 decisions for Biomedix, Inc. (Spencer, IN) from 1993 to 2014: 11 510(k) clearances. Most are in product codes JOM (Plethysmograph, Photoelectric, Pneumatic Or…) and FPA (Set, Administration, Intravascular). Its devices cite 9 predicates, 6 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2014

2007: 12012: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Biomedix, 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?

  • JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic3decisions
  • FPASet, Administration, Intravascular3decisions
  • CGAGlucose Oxidase, Glucose2decisions
  • JAFMonitor, Ultrasonic, Nonfetal2decisions
  • BTRTube, Tracheal (W/Wo Connector)1decision

Whose devices does it build on?

Its devices cite 9 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 6 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.

  • K042616Biomedix Padnet LabBiomedix, Inc. · 20043cite it
  • K973644Flostat Vascular LabBiomedix, Inc. · 19973cite it
  • K122281Padnet 2.0Biomedix, Inc. · 20121cites it
  • K073146Padnet+Biomedix, Inc. · 20071cites it
  • K925645SELEC-3Biomedix, Inc. · 19931cites it
  • K033627Q.Steps Biometer G Blood Glucose Monitoring SystemBiomedix, Inc. · 20041cites it

What has FDA decided for it lately?

  • K142097Selec-3 I.V.Administration SetBiomedix, Inc. · 20141 recall
  • K122281Padnet 2.0Biomedix, Inc. · 2012
  • K073146Padnet+Biomedix, Inc. · 2007
  • K050182Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc. · 2005
  • K042616Biomedix Padnet LabBiomedix, Inc. · 2004
  • K033627Q.Steps Biometer G Blood Glucose Monitoring SystemBiomedix, Inc. · 2004
  • K973857Flostat Vascular Report Generator (VRG)Biomedix, Inc. · 1997
  • K973644Flostat Vascular LabBiomedix, Inc. · 1997

All 11 as Biomedix, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142097Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET…Aug 14, 2014Class II