Cleared Traditional

K861418 - SPINNAKER

K861418 is the FDA 510(k) clearance for SPINNAKER by Cybermedic, Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

Device Classification

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 8
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K861418.
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Q-PLEX 1
K881235 · Quinton, Inc. · Mar 1989
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
K810751 · General Electric Co. · Apr 1981
INSPIRON PULMONARY FUNCTION ANALYZER
K802920 · C.R. Bard, Inc. · Feb 1981
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K802116 · Puritan Bennett Corp. · Oct 1980