510(k) Report

FDA applicant

J. H. Emerson Co.

Cambridge, MA25 decisions1981–20000 recalls

FDA records 25 decisions for J. H. Emerson Co. (Cambridge, MA) from 1981 to 2000: 25 510(k) clearances. Most are in product codes BYT (Ventilator, External Body, Negative Pressure…) and NHJ (Device, Positive Pressure Breathing…). 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, anesthesiology panel, where it files most

How often FDA has decided J. H. Emerson Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for J. H. Emerson Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — J. H. Emerson Co. 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?

  • BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)3decisions
  • NHJDevice, Positive Pressure Breathing, Intermittent2decisions
  • IQASystem, Environmental Control, Powered2decisions
  • CBKVentilator, Continuous, Facility Use2decisions
  • GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2decisions
  • KQTEvacuator, Gastro-Urology1decision

Also: IKZ (1), GBS (1), FMT (1), LGM (1), KDQ (1), BTL (1).

Who builds on its devices?

Later devices cite its devices 8 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.

  • K002598Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingJ. H. Emerson Co. · 20007cite it
  • K864394Emerson 3MV Volume VentilatorJ. H. Emerson Co. · 19861cites it

What has FDA decided for it lately?

  • K002598Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingJ. H. Emerson Co. · 2000
  • K920910Oxygen Powered Resuscitator for CPRJ. H. Emerson Co. · 1993
  • K924174Emerson in-Exsufflator, Models 2-CM & 2-CAJ. H. Emerson Co. · 1992
  • K902764Emerson 33-an Negative Pressure Respirator AlarmJ. H. Emerson Co. · 1990
  • K896721Model 7-at Treatment ChamberJ. H. Emerson Co. · 1990
  • K881808Emerson Chest Respirator, Model 33-CreJ. H. Emerson Co. · 1988
  • K873489Emerson Dispos Thoracic Drainage Set - 551-8000J. H. Emerson Co. · 1987
  • K87293797-TD Emerson Timer/Dimmer ControlJ. H. Emerson Co. · 1987

All 25 as J. H. Emerson Co. →