Cleared Traditional

K914965 - DISPOSABLE STYLETTE WITH END CAP

K914965 is an FDA 510(k) clearance for DISPOSABLE STYLETTE WITH END CAP, manufactured by Pivic Promedco. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K914965 · Pivic Promedco · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
204d
Days
Class 1
Risk

K914965 is an FDA 510(k) clearance for the DISPOSABLE STYLETTE WITH END CAP. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Pivic Promedco (Orange, US). The FDA issued a Cleared decision on May 27, 1992 after a review of 204 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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.

FDA 510(k) Submission Details - K914965

510(k) Number K914965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date May 27, 1992
Days to Decision 204 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
64d slower than avg
Panel avg: 140d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
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 - BSR Stylet, Tracheal Tube

All 24
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K914965.
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE
K935797 · Stebar Instrument Corp. · Jan 1994
LIGHTED INTUBATION SYLET
K932081 · Aaron Medical, Inc. · Jul 1993
STYLET AND TRACHEAL LIGHTWAND (STL)
K922842 · Laerdal California, Inc. · Dec 1992
AUGUSTINE STYLET
K920468 · Augustine Medical, Inc. · Apr 1992
AUGUSTINE GUIDE(TM) KIT
K912690 · Augustine Medical, Inc. · Sep 1991
AUGUSTINE STYLET
K910659 · Augustine Medical, Inc. · May 1991