510(k) Report

FDA applicant

Hood Laboratories

Pembroke, MA19 decisions1985–19935 recalls

FDA records 19 decisions for Hood Laboratories (Pembroke, MA) from 1985 to 1993: 19 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and FWN (Prosthesis, Larynx (Stents And Keels)). 5 recalls are linked to its devices, 1 Class I.

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 Hood Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hood Laboratories since 2007.

Recalls per year

1in 2013

2013: 1, 1 Class I
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hood Laboratories 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?

  • BTOTube, Tracheostomy (W/Wo Connector)4decisions
  • FWNProsthesis, Larynx (Stents And Keels)2decisions
  • ESWProsthesis, Esophageal2decisions
  • KYFImplant, Eye Valve2decisions
  • EWLProsthesis, Laryngeal (Taub)2decisions
  • NWAProsthesis, Tracheal, Preformed/Molded1decision

Also: JOH (1), LFB (1), BTR (1), ESZ (1), BXQ (1), EPP (1).

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K921452Acoustic RhinometerHood Laboratories · 19931cites it

What has FDA decided for it lately?

  • K921452Acoustic RhinometerHood Laboratories · 1993
  • K920994Hood Nasal Septal ButtonHood Laboratories · 1992
  • K905703Krupin Eye Valve with DiskHood Laboratories · 19914 recalls
  • K904821Eliachar Modified Esophageal StentHood Laboratories · 1991
  • K897049Gibson Endolymphatic ShuntHood Laboratories · 1990
  • K897059Hood Speaking ValveHood Laboratories · 1990
  • K893866Hood Pediatric Tracheostomy TubeHood Laboratories · 19891 Class I recall
  • K884810Silicone Laryngeal StentHood Laboratories · 1989

All 19 as Hood Laboratories →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K893866Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide…Apr 17, 2013Class I
  • K905703Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209VApr 12, 2006
  • K905703Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365VApr 12, 2006
  • K905703Krupin Eye Valve, P/N 6003Apr 12, 2006
  • K905703Valve-EV Glaucoma Ultra-Smooth, P/N 6006Apr 12, 2006