Cleared Traditional

K960854 - SIEMENS SERVO ULTRA NEBULIZER 345

K960854 is an FDA 510(k) clearance for SIEMENS SERVO ULTRA NEBULIZER 345, manufactured by Pacesetter, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K960854 · Pacesetter, Inc. · Anesthesiology device
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Dec 1996
Decision
297d
Days
Class 2
Risk

K960854 is an FDA 510(k) clearance for the SIEMENS SERVO ULTRA NEBULIZER 345. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pacesetter, Inc. (North Attleboro, US). The FDA issued a Cleared decision on December 23, 1996 after a review of 297 days - an extended review 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: 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 Pacesetter, Inc. devices

FDA 510(k) Submission Details - K960854

510(k) Number K960854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1996
Decision Date December 23, 1996
Days to Decision 297 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 140d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - CAF Nebulizer (direct Patient Interface)

All 285
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K960854.
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OPTICHAMBER
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