Cleared Traditional

K861418 - SPINNAKER

K861418 is an FDA 510(k) clearance for SPINNAKER, manufactured by Cybermedic, Inc.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K861418 · Cybermedic, Inc. · Anesthesiology device
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May 1986
Decision
24d
Days
Class 2
Risk

K861418 is an FDA 510(k) clearance for the SPINNAKER. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Cybermedic, Inc. (Boulder, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 Cybermedic, Inc. devices

FDA 510(k) Submission Details - K861418

510(k) Number K861418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date May 09, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 51
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K861418.
OS-1 OCCLUSION SYSTEM - 1
K894839 · Medical, Inc. · Oct 1989
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STAR CALC
K875027 · Infrasonics Corp. · Aug 1988
ALVEO-DIFFUSION TEST
K853443 · Erich Jaeger, Inc. · Feb 1986
OXYSCREEN
K843860 · Erich Jaeger, Inc. · Dec 1984
AW TEST
K843848 · Erich Jaeger, Inc. · Nov 1984