510(k) Report

FDA applicant

Sharn, Inc.

Tampa, FL4 decisions1986–20073 recalls

FDA records 4 decisions for Sharn, Inc. (Tampa, FL) from 1986 to 2007: 4 510(k) clearances. Most are in product codes CCT (Applicator (Laryngo-Tracheal), Topical…) and BZW (Stethoscope, Esophageal). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are 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 Sharn, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

3in 2009

2009: 3
2007high 3 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sharn, 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?

  • CCTApplicator (Laryngo-Tracheal), Topical Anesthesia1decision
  • BZWStethoscope, Esophageal1decision
  • CAOAirway, Esophageal (Obturator)1decision
  • CCXSupport, Patient Position1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K070596Topical ApplicatorSharn, Inc. · 20071cites it

What has FDA decided for it lately?

  • K070596Topical ApplicatorSharn, Inc. · 20073 recalls
  • K932305Vila-Cooke (TM) Anesthesia PillowSharn, Inc. · 1993
  • K894032Evac-TubeSharn, Inc. · 1989
  • K860558Esophageal StethoscopeSharn, Inc. · 1986

All 4 as Sharn, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K070596Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only…Mar 5, 2009
  • K070596Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only…Mar 5, 2009
  • K070596Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single…Mar 5, 2009