Cleared Traditional

K771116 - CATHETER, PO2, INTRAVASUCLAR, CITADEL

K771116 is an FDA 510(k) clearance for CATHETER, manufactured by Sherwood Medical Industries. The device is a Class 2 Anesthesiology device with product code CCE cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K771116 · Sherwood Medical Industries · Anesthesiology device
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Sep 1977
Decision
91d
Days
Class 2
Risk

K771116 is an FDA 510(k) clearance for the CATHETER, PO2, INTRAVASUCLAR, CITADEL. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on September 15, 1977 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 868.1200 - 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 Sherwood Medical Industries devices

FDA 510(k) Submission Details - K771116

510(k) Number K771116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1977
Decision Date September 15, 1977
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

CCE Device Classification - Class 2, Special Controls

Product Code CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1200
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 - CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

All 15
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K771116.
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
K860106 · American Bentley · Feb 1986
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
K853786 · American Bentley · Oct 1985
VENOUS OXYGEN PROBE
K811071 · G.D. Searle and Co. · May 1981
MONITOR, CITADEL INTRAVASCULAR PO2
K760350 · Sherwood Medical Industries · Oct 1976