510(k) Report

FDA applicant

Electromedics, Inc.

Englewood, CO42 decisions1977–20083 recalls

FDA records 42 decisions for Electromedics, Inc. (Englewood, CO) from 1977 to 2008: 42 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and CAC (Apparatus, Autotransfusion). Its devices cite 4 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Electromedics Co. , Ltd.”.

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 Electromedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

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

2026 so far, outlined.

Recalls per year

2in 2018

2007: 12018: 2
2007high 2 (2018) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Electromedics, 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?

  • FLLContinuous Measurement Thermometer10decisions
  • CACApparatus, Autotransfusion7decisions
  • DTNReservoir, Blood, Cardiopulmonary Bypass5decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass3decisions
  • DRSTransducer, Blood-Pressure, Extravascular2decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2decisions

Also: BYZ (1), LDQ (1), DWB (1), DTZ (1), DWE (1), KCY (1).

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K910238Portable Auto Transfusion System 500Electromedics, Inc. · 19913cite it
  • K803277Tygon TubingElectromedics, Inc. · 19812cite it
  • K830592Dispos. Type T Thermocouple Temp.ProbeElectromedics, Inc. · 19831cites it
  • K915737Autotransfusion Blood Collection ReservoirElectromedics, Inc. · 19921cites it
  • K813459Reusable & Disposable Temp. ProbesElectromedics, Inc. · 19821cites it
  • K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 20081cites it

What has FDA decided for it lately?

  • K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008
  • K934964Electromedics Tympanic Temperature SensorElectromedics, Inc. · 1994
  • K933832Electromedics HG (Hydrogel) Series Skin Temperature SensorElectromedics, Inc. · 1994
  • K934355Electromedics Blood Heat ExchangerElectromedics, Inc. · 1993
  • K930154EL2-Series Blood Collection ReervoirElectromedics, Inc. · 19931 recall
  • K926250Electromedics EL-Series Cardiotomy ReservoirElectromedics, Inc. · 1993
  • K925412Electromedics Tissue Trap/ #TT280Electromedics, Inc. · 1993
  • K915737Autotransfusion Blood Collection ReservoirElectromedics, Inc. · 1992

All 41 as Electromedics, Inc. →The one decision as Electromedics Co., Ltd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K803277RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are…Nov 27, 2018Class II
  • K812292SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation…Nov 27, 2018Class II
  • K930154Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc.…Oct 1, 2007