Cleared Traditional

K921809 - COMPANION 800 PORTABLE NEBULIZER COMPRE...

K921809 is an FDA 510(k) clearance for COMPANION 800 PORTABLE NEBULIZER COMPRE..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K921809 · Puritan Bennett Corp. · Anesthesiology device
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Dec 1992
Decision
233d
Days
Class 2
Risk

K921809 is an FDA 510(k) clearance for the COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on December 4, 1992 after a review of 233 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K921809

510(k) Number K921809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1992
Decision Date December 04, 1992
Days to Decision 233 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 140d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 190
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K921809.
SOFT-MIST(TM)
K924649 · Vortran Medical Technology 1, Inc. · May 1993
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K923888 · Devilbiss Health Care, Inc. · Feb 1993
PRECISION MIST COMPRESSOR
K923324 · Precision Medical, Inc. · Jan 1993
SAM LS
K913095 · Ferguson Medical · Dec 1992
SAM SC
K913096 · Ferguson Medical · Dec 1992
HEART NEBULIZER
K923596 · Vortran Medical Technology 1, Inc. · Oct 1992