Cleared Traditional

K832928 - SERVO HEATED RESPIRATORY HUMIDIFIER

K832928 is an FDA 510(k) clearance for SERVO HEATED RESPIRATORY HUMIDIFIER, manufactured by Fisher & Paykel Allied Products , Ltd.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K832928 · Fisher & Paykel Allied Products , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
93d
Days
Class 2
Risk

K832928 is an FDA 510(k) clearance for the SERVO HEATED RESPIRATORY HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Allied Products , Ltd. (Panmure, New Zealand, NZ). The FDA issued a Cleared decision on November 25, 1983 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K832928

510(k) Number K832928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1983
Decision Date November 25, 1983
Days to Decision 93 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 140d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 184
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K832928.
NEBULO 28 NEBULIZER KIT
K841158 · Inspiron Corp. · Mar 1984
CONCHATHERM LHF HUMIDIFIER HEATER
K834151 · Respiratory Care, Inc. · Jan 1984
AQUAPAK 020 HUMIDIFIER ADAPTER
K833974 · Respiratory Care, Inc. · Dec 1983
A QUAPAK
K811073 · Respiratory Care, Inc. · Apr 1981
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K810939 · Allied Healthcare Products, Inc. · Apr 1981
OPTI- SYSTEM
K810559 · Corpak Co. · Mar 1981
K832928 · SERVO HEATED RESPIRATORY HUMIDIFIER
Download PDF Fisher & Paykel Allie…