Cleared Traditional

K982242 - INVACARE CPAP

K982242 is an FDA 510(k) clearance for INVACARE 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 216-day FDA review.

K982242 · Invacare Corp. · Anesthesiology device
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Jan 1999
Decision
216d
Days
Class 2
Risk

K982242 is an FDA 510(k) clearance for the INVACARE CPAP. 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 January 27, 1999 after a review of 216 days - an extended review cycle.

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. 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.

View all Invacare Corp. devices

FDA 510(k) Submission Details - K982242

510(k) Number K982242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1998
Decision Date January 27, 1999
Days to Decision 216 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
76d slower than avg
Panel avg: 140d · This submission: 216d
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 K982242.
SULLIVAN AUTOSET NASAL CPAP SYSTEM
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REUSABLE CONTOUR II NASAL MASK
K991648 · Respironics, Inc. · May 1999
INFANT FLOW NCPAP MASKS
K984254 · Sensor Medics Corp. · Feb 1999
SULLIVAN MIRAGE FULL FACE MASK
K982530 · Resmed, Ltd. · Oct 1998
SULLIVAN AUTOSET
K980721 · Resmed, Ltd. · Sep 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365 · Nellcor Puritan Bennett, Inc. · Jul 1998