Cleared Traditional

K951366 - RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)

K951366 is an FDA 510(k) clearance for RIKEN GAS INDICATOR (3 MODELS, manufactured by Riken Keiki Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K951366 · Riken Keiki Co., Ltd. · Anesthesiology device
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Aug 1995
Decision
128d
Days
Class 2
Risk

K951366 is an FDA 510(k) clearance for the RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18). Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Riken Keiki Co., Ltd. (Wales Center, US). The FDA issued a Cleared decision on August 2, 1995 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - 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 Riken Keiki Co., Ltd. devices

FDA 510(k) Submission Details - K951366

510(k) Number K951366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date August 02, 1995
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBS Device Classification - Class 2, Special Controls

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
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 - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

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