Cleared Traditional

K980551 - SILENZIO DELTA CONTINUOUS POSITIVE AIRW...

K980551 is the FDA 510(k) clearance for SILENZIO DELTA CONTINUOUS POSITIVE AIRW... by Nidek Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K980551 · Nidek Medical Products, Inc. · Anesthesiology device
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Nov 1998
Decision
278d
Days
Class 2
Risk

K980551 is an FDA 510(k) clearance for the SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on November 17, 1998 after a review of 278 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 Nidek Medical Products, Inc. devices

Submission Details

510(k) Number K980551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1998
Decision Date November 17, 1998
Days to Decision 278 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
138d slower than avg
Panel avg: 140d · This submission: 278d
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 247
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K980551.
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SULLIVAN MIRAGE FULL FACE MASK
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K980721 · Resmed, Ltd. · Sep 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365 · Nellcor Puritan Bennett, Inc. · Jul 1998