Cleared Traditional

7300 NASAL CPAP SYSTEM (K943509) - FDA 510(k) Clearance

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

K943509 · Healthdyne Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
16d
Days
Class 2
Risk

K943509 is an FDA 510(k) clearance for the 7300 NASAL CPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Healthdyne Technologies, Inc. (Marietta, US). The FDA issued a Cleared decision on August 5, 1994 after a review of 16 days - a notably fast clearance 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: 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 Healthdyne Technologies, Inc. devices

Submission Details

510(k) Number K943509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1994
Decision Date August 05, 1994
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K943509.
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
K952292 · Puritan Bennett Corp. · Nov 1995
SPECTRUM(TM) MASK
K936047 · Respironics, Inc. · Mar 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804 · Puritan Bennett Corp. · Feb 1995
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
TOTAL FACE MASK
K925920 · Respironics, Inc. · Jul 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590 · Puritan Bennett Corp. · Apr 1993