Cleared Traditional

K954383 - SURELOC CIRCUIT CONNECTOR

K954383 is an FDA 510(k) clearance for SURELOC CIRCUIT CONNECTOR, manufactured by Polamedco, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K954383 · Polamedco, Inc. · Anesthesiology device
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Dec 1995
Decision
94d
Days
Class 1
Risk

K954383 is an FDA 510(k) clearance for the SURELOC CIRCUIT CONNECTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Polamedco, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 Polamedco, Inc. devices

FDA 510(k) Submission Details - K954383

510(k) Number K954383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date December 22, 1995
Days to Decision 94 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
46d faster than avg
Panel avg: 140d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZA Connector, Airway (extension)

All 63
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K954383.
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