Cleared Traditional

K031176 - INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031176 · Invacare Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
346d
Days
Class 2
Risk

K031176 is an FDA 510(k) clearance for the INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 25, 2004 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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

View all Invacare Corp. devices

Submission Details

510(k) Number K031176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date March 25, 2004
Days to Decision 346 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 139d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 220
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K031176.
HVT 2.0
K254078 · Vapotherm, Inc. · Apr 2026
FL-10000U Respiratory Humidifier
K251448 · Flexicare Medical Limited. · Jan 2026
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K251419 · Laboratorios Biogalenic S.A. DE C.V. · Jan 2026
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
K253479 · Fisher &Paykel Healthcare , Ltd. · Dec 2025
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant
K250312 · Medline Industries, LP · Jul 2025
Optiflow+ Nasal Cannula - Small (OPT942)
K251611 · Fisher &Paykel Healthcare , Ltd. · Jun 2025