510(k) Report

FDA applicant

Sheridan Catheter Corp.

Argyle, NY39 decisions1982–199337 recalls

FDA records 39 decisions for Sheridan Catheter Corp. (Argyle, NY) from 1982 to 1993: 39 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and FLL (Continuous Measurement Thermometer). 37 recalls are linked to its devices, 18 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 Sheridan Catheter Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sheridan Catheter Corp. since 2007.

Recalls per year

18in 2019

2009: 72014: 12015: 2, 1 Class I2016: 22019: 18, 17 Class I
2007high 18 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sheridan Catheter Corp. 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?

  • BTRTube, Tracheal (W/Wo Connector)11decisions
  • FLLContinuous Measurement Thermometer5decisions
  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • BZTStethoscope, Esophageal, With Electrical Conductors4decisions
  • CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2decisions
  • GBSCatheter, Ventricular, General & Plastic Surgery2decisions

Also: KOD (2), BSY (2), BZA (1), BSR (1), BYY (1), CAO (1).

Who builds on its devices?

Later devices cite its devices 16 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.

  • K860105Spiral-FlexSheridan Catheter Corp. · 19863cite it
  • K844296Tracheal Tube, Reinforced, CuffedSheridan Catheter Corp. · 19843cite it
  • K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 19822cite it
  • K862347Endotracheal Tube, AccessorySheridan Catheter Corp. · 19862cite it
  • K861454End Tidal CO2 TubeSheridan Catheter Corp. · 19861cites it
  • K850964Double-Swivel ConnectorSheridan Catheter Corp. · 19851cites it

What has FDA decided for it lately?

  • K922894Lazer-Trach Tracheal TubeSheridan Catheter Corp. · 1993
  • K897046Laser Resistant Tracheal TubeSheridan Catheter Corp. · 1990
  • K890823Accessory to Clinical Electronic ThermometerSheridan Catheter Corp. · 1989
  • K884765Clinical Electronic ThermometersSheridan Catheter Corp. · 1989
  • K882918Kim Naso-Intestinal TubeSheridan Catheter Corp. · 1988
  • K882127Clinical Electronic ThermometersSheridan Catheter Corp. · 1988
  • K881368Clinical Electonic ThermometersSheridan Catheter Corp. · 1988
  • K881293Sheridan Electrosurgery Protection FilterSheridan Catheter Corp. · 1988

All 39 as Sheridan Catheter Corp. →

What has been recalled?

37 recalls linked to its devices; the latest:

  • K851856HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The…Oct 30, 2019Class II
  • K822082Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm…Jul 30, 2019Class I
  • K822082Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF…Jul 30, 2019Class I
  • K822082Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c)…Jul 30, 2019Class I
  • K822082Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway managementJul 30, 2019Class I
  • K822082Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF…Jul 30, 2019Class I