Cleared Traditional

K031064 - INVACARE POLARIS EX CPAP

K031064 is an FDA 510(k) clearance for INVACARE POLARIS EX CPAP, manufactured by Invacare Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K031064 · Invacare Corp. · Anesthesiology device
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Mar 2004
Decision
344d
Days
Class 2
Risk

K031064 is an FDA 510(k) clearance for the INVACARE POLARIS EX CPAP, MODEL ISP3000. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 12, 2004 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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

FDA 510(k) Submission Details - K031064

510(k) Number K031064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2003
Decision Date March 12, 2004
Days to Decision 344 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 140d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K031064.
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
K041010 · Respironics, Inc. · May 2004
OXYGEN DIVERTER VALVE
K033914 · Resmed, Ltd. · Apr 2004
RESMED HOSPITAL NASAL MASK
K040566 · Resmed, Ltd. · Apr 2004
RESMED S8 PRIME CPAP SYSTEM
K033841 · Resmed, Ltd. · Mar 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004