Cleared Traditional

K953351 - SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS

K953351 is an FDA 510(k) clearance for SEATRONICS FAMILY OF GALVANIC OXYGEN SE..., manufactured by Seatronics Co.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K953351 · Seatronics Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
91d
Days
Class 2
Risk

K953351 is an FDA 510(k) clearance for the SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Seatronics Co. (Hatboro, US). The FDA issued a Cleared decision on October 16, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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 Seatronics Co. devices

FDA 510(k) Submission Details - K953351

510(k) Number K953351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date October 16, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 76
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K953351.
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
K943824 · Ametek, Inc. · Nov 1996
MINIOX 3000 OXYGEN MONITOR
K961644 · Minesafety Appliances Co. · Jul 1996
OXYCHECK OXYGEN MONITOR
K951038 · Oxycheck, Inc. · Jan 1996
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
K941793 · Mountain Medical Equipment, Inc. · Jun 1995
OXYGEN CONCENTRATION INDICATOR
K944654 · Aequitron Medical, Inc. · Nov 1994
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338 · Puritan Bennett Corp. · Aug 1992