Cleared Traditional

K831427 - CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.

K831427 is an FDA 510(k) clearance for CYPRANE TEC 4 CONTINUOUS FLOW VAPOR., manufactured by Fraser Harlake, Inc.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K831427 · Fraser Harlake, Inc. · Anesthesiology device
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Jul 1983
Decision
65d
Days
Class 2
Risk

K831427 is an FDA 510(k) clearance for the CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Fraser Harlake, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - 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 Fraser Harlake, Inc. devices

FDA 510(k) Submission Details - K831427

510(k) Number K831427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1983
Decision Date July 07, 1983
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 - CAD Vaporizer, Anesthesia, Non-heated

All 36
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K831427.
VAPAMASTA 5
K884686 · Dentsply Intl. · Mar 1989
VAPLOK
K864605 · Bear Medical Systems, Inc. · Feb 1987
HALOTHANE VAPORIZER 950, ENFLURANE
K841157 · Siemens Elema AB · Jun 1984
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K821966 · Ohio Medical Products · Jul 1982
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650 · Draeger Medical, Inc. · Jun 1982
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K810289 · Ohio Medical Products · Mar 1981