Cleared Traditional

K032809 - HOSPITAL SPACER

K032809 is an FDA 510(k) clearance for HOSPITAL SPACER, manufactured by Respironics Healthscan, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K032809 · Respironics Healthscan, Inc. · Anesthesiology device
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Nov 2003
Decision
65d
Days
Class 2
Risk

K032809 is an FDA 510(k) clearance for the HOSPITAL SPACER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respironics Healthscan, Inc. (Great Neck, US). The FDA issued a Cleared decision on November 13, 2003 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Respironics Healthscan, Inc. devices

FDA 510(k) Submission Details - K032809

510(k) Number K032809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date November 13, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 416
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K032809.
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)
K031908 · Med2000 S.R.L. · Jan 2004
AEROCHAMBER MAX VALVED HOLDING CHAMBER
K032972 · Trudell Medical Intl. · Jan 2004
AERONEB GO NEBULIZER, MODEL AG-AG2000
K032849 · Aerogen, Inc. · Nov 2003
SONIK LDI 20 AIR
K030374 · Evit Labs, Inc. · Aug 2003
SMALL VOLUME NEBULIZER
K023602 · Allegiance Healthcare Corporation · May 2003
GALEMED NEB-EASY NEBULIZER
K021742 · Galemed Corp. · Oct 2002