Cleared Traditional

K912652 - FLEX-ELBOW

K912652 is an FDA 510(k) clearance for FLEX-ELBOW, manufactured by Vital Signs, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K912652 · Vital Signs, Inc. · Anesthesiology device
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Oct 1991
Decision
115d
Days
Class 1
Risk

K912652 is an FDA 510(k) clearance for the FLEX-ELBOW. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on October 10, 1991 after a review of 115 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K912652

510(k) Number K912652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1991
Decision Date October 10, 1991
Days to Decision 115 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
25d faster than avg
Panel avg: 140d · This submission: 115d
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 58
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K912652.
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993
CATHETER MOUNTS -- MODIFICATION
K921511 · Intersurgical, Inc. · Jun 1992
ENTENDED LINE ACCESSORIES & CONNECTORS
K921512 · Intersurgical, Inc. · Jun 1992
CATHETER MOUNTS
K911421 · Intersurgical, Inc. · Jun 1991
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
K911425 · Intersurgical, Inc. · Jun 1991
AEROVENT
K894969 · Monaghan Medical Corp. · Oct 1989