510(k) Report

FDA applicant

Spectramed, Inc.

Oxnard, CA13 decisions1987–19901 recall

FDA records 13 decisions for Spectramed, Inc. (Oxnard, CA) from 1987 to 1990: 13 510(k) clearances. Most are in product codes KXO (Monitor, Pressure, Intrauterine) and LDF (Electrode, Pacemaker, Temporary). 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 Spectramed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectramed, Inc. since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • KXOMonitor, Pressure, Intrauterine4decisions
  • LDFElectrode, Pacemaker, Temporary1decision
  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function1decision
  • DQOCatheter, Intravascular, Diagnostic1decision
  • KRBProbe, Thermodilution1decision
  • DSKComputer, Blood-Pressure1decision

Also: DQY (1), DQF (1), DYB (1), DRS (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K892941Cco System Model SP1467,SP5567,SP6267Spectramed, Inc. · 19891cites it
  • K873168Spectramed Disposable Transducer (DT-Xxo) & AccessSpectramed, Inc. · 19881cites it

What has FDA decided for it lately?

  • K896122Amnicathdl (TM) DT-IUPC2 Dual Lumen Trans. TippedSpectramed, Inc. · 1990
  • K892941Cco System Model SP1467,SP5567,SP6267Spectramed, Inc. · 1989
  • K895323Model DT-Bal, Balance SaverSpectramed, Inc. · 1989
  • K894362Model DT-IUPC2 Transducer Tipped Dual Lumen IupSpectramed, Inc. · 1989
  • K881857Amnicath (TM) Model DT-Iupc Trans. Tipped Intrau.Spectramed, Inc. · 1989
  • K885235Safe-Draw (TM) Blood Sampling Reservoir & Access.Spectramed, Inc. · 19891 recall
  • K881825Models SP5825/SP5835/SP5845/SP5855 Percu. SheathSpectramed, Inc. · 1988
  • K875337Heparin Coated Luminal Pacing CatheterSpectramed, Inc. · 1988

All 13 as Spectramed, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K885235Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag…May 4, 2012Class II