Bottle, Condensate (#1628)

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K760082 ↗

FDA Product Code

CBC

Device Class

Class II

Regulation

21 CFR Part 880.6740

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Manifold & Nebu. for Single Line Mach.

  Class II

  FDA 510(k) K772071 Active Cleared 15 Nov 1977

• Pediatric Anesthesia Circuit

  Class I

  FDA 510(k) K770549 Active Cleared 30 Mar 1977

• Filter, Bacteria (#2290)

  Class II

  FDA 510(k) K760081 Active Cleared 15 Jul 1976

• Inspiron Liquid Oxygen System

  Class II

  FDA 510(k) K834290 Active Cleared 4 Feb 1984

• Cannula, Nasal, for Oxygen

  Class I

  FDA 510(k) K760080 Active Cleared 15 Jul 1976

• Vapor-Phase Humidifier Sys-Advanced

  Class II

  FDA 510(k) K843932 Active Cleared 18 Oct 1984

See all devices from Inspiron Corp. →

• What is the BOTTLE, CONDENSATE (#1628) used for?

  The BOTTLE, CONDENSATE (#1628) is designed to collect condensate from breathing circuits in respiratory care settings, as defined by its FDA classification as a Bottle, Collection And Trap, Breathing System (Uncalibrated). This function prevents fluid buildup that could interfere with ventilator performance or patient safety during respiratory therapy.

• Is the BOTTLE, CONDENSATE (#1628) reusable or single-use?

  The device is supplied as a reusable device, meaning it is intended for multiple uses after appropriate cleaning and disinfection between patients, in accordance with the manufacturer's instructions and hospital reprocessing protocols for respiratory equipment.

• What regulatory pathway was used for the BOTTLE, CONDENSATE (#1628)?

  The BOTTLE, CONDENSATE (#1628) was cleared via FDA 510(k) submission K760082, demonstrating substantial equivalence to a legally marketed predicate device under product code CBC and regulation 880.6740, which governs breathing system condensate traps.