Cleared Traditional

K980551 - SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

K980551 is an FDA 510(k) clearance for SILENZIO DELTA CONTINUOUS POSITIVE AIRW..., manufactured by Nidek Medical Products, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K980551

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
Combination Product No
PCCP Authorized No
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.

BZD Device Classification - Class 2, Special Controls

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 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K980551.
NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
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INFANT FLOW NCPAP MASKS
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INVACARE CPAP
K982242 · Invacare Corp. · Jan 1999
SULLIVAN MIRAGE FULL FACE MASK
K982530 · Resmed, Ltd. · Oct 1998
COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
K981744 · W. Keith Thornton, D.D.S. · Oct 1998
SULLIVAN AUTOSET
K980721 · Resmed, Ltd. · Sep 1998