510(k) Report

FDA applicant

Polamedco, Inc.

Mchenry, IL20 decisions1978–199928 recalls

FDA records 20 decisions for Polamedco, Inc. (Mchenry, IL) from 1978 to 1999: 20 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and BSR (Stylet, Tracheal Tube). Its devices cite 1 predicate, 0 of them its own earlier devices. 28 recalls are linked to its devices, 26 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 Polamedco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polamedco, Inc. since 2007.

Recalls per year

26in 2023

2021: 12022: 12023: 26, 26 Class I
2007high 26 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Polamedco, 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?

  • BTRTube, Tracheal (W/Wo Connector)7decisions
  • BSRStylet, Tracheal Tube2decisions
  • BTQAirway, Nasopharyngeal2decisions
  • BZAConnector, Airway (Extension)2decisions
  • BSSTube, Nasogastric1decision
  • FWZOperating Room Accessories Table Tray1decision

Also: KNA (1), BTO (1), FXX (1), BZT (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K983000Cricothyrotomy TubePolamedco, Inc. · 1999
  • K954383Sureloc Circuit ConnectorPolamedco, Inc. · 1995
  • K953793IntroscopePolamedco, Inc. · 1995
  • K950713Airguide StylettePolamedco, Inc. · 1995
  • K933596Gastric, Catheter, Irrigation & AspirationPolamedco, Inc. · 1995
  • K950380Flextitip StylettePolamedco, Inc. · 1995
  • K920900Polamedco Tracheal and Nasotracheal TubesPolamedco, Inc. · 1992
  • K900456Polamedco Nasopaharyngeal AirwayPolamedco, Inc. · 1990

All 20 as Polamedco, Inc. →

What has been recalled?

28 recalls linked to its devices; the latest:

  • K780900Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140May 25, 2023Class I
  • K780900Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060May 25, 2023Class I
  • K780900Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150May 25, 2023Class I
  • K780900Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145May 25, 2023Class I
  • K780900Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025May 25, 2023Class I
  • K780900Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040May 25, 2023Class I