Cleared Traditional

HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 (K990856) - FDA 510(k) Clearance

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

K990856 · Bird Products Corp. · Anesthesiology device
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Jan 2000
Decision
302d
Days
Class 2
Risk

K990856 is an FDA 510(k) clearance for the HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 302 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 Bird Products Corp. devices

Submission Details

510(k) Number K990856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date January 11, 2000
Days to Decision 302 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 140d · This submission: 302d
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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K990856.
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · Respironics, Inc. · Sep 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · Respironics, Inc. · Sep 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · Respironics, Inc. · Jun 2000
RESPIRONICS TOTAL FACE MASK
K992969 · Respironics, Inc. · Nov 1999
ARIA LX CPAP SYSTEM
K993307 · Respironics, Inc. · Oct 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · Respironics, Inc. · Oct 1999