Cleared Traditional

K963177 - TED 191

K963177 is an FDA 510(k) clearance for TED 191, manufactured by Teledyne Brown Engineering. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K963177 · Teledyne Brown Engineering · Anesthesiology device
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Nov 1997
Decision
456d
Days
Class 2
Risk

K963177 is an FDA 510(k) clearance for the TED 191. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Teledyne Brown Engineering (Washington, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Teledyne Brown Engineering devices

FDA 510(k) Submission Details - K963177

510(k) Number K963177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date November 13, 1997
Days to Decision 456 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 140d · This submission: 456d
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 65
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K963177.
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VENTREX OXYGEN SENSOR
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K943824 · Ametek, Inc. · Nov 1996
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K961644 · Minesafety Appliances Co. · Jul 1996