510(k) Report

FDA applicant

International Biomedics, Inc.

Bothell, WA5 decisions1985–20030 recalls

FDA records 5 decisions for International Biomedics, Inc. (Bothell, WA) from 1985 to 2003: 5 510(k) clearances. Most are in product codes FPL (Incubator, Neonatal Transport) and HGM (System, Monitoring, Perinatal). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for International Biomedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like International Biomedics, 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?

  • FPLIncubator, Neonatal Transport1decision
  • HGMSystem, Monitoring, Perinatal1decision
  • HFMMonitor, Uterine Contraction, External (For Use In Clinic)1decision
  • HGLTransducer, Ultrasonic, Obstetric1decision
  • HEMImager, Ultrasonic Obstetric-Gynecologic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K031096Modification to Transport Incubator 185International Biomedics, Inc. · 20033cite it

What has FDA decided for it lately?

  • K031096Modification to Transport Incubator 185International Biomedics, Inc. · 2003
  • K860933Air-Cushion TocotonometerInternational Biomedics, Inc. · 1986
  • K862072Fetascan Ultrasound Transducer Ibi# 101B00054-01International Biomedics, Inc. · 1986
  • K860295Fetascan 1500International Biomedics, Inc. · 1986
  • K852439Feta Scan 1000 Obstetrical ImagerInternational Biomedics, Inc. · 1985

All 5 as International Biomedics, Inc. →