Cleared Traditional

K921511 - CATHETER MOUNTS -- MODIFICATION

K921511 is an FDA 510(k) clearance for CATHETER MOUNTS -- MODIFICATION, manufactured by Intersurgical, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K921511 · Intersurgical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
85d
Days
Class 1
Risk

K921511 is an FDA 510(k) clearance for the CATHETER MOUNTS -- MODIFICATION. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Intersurgical, Inc. (Cazenovia, US). The FDA issued a Cleared decision on June 17, 1992 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intersurgical, Inc. devices

FDA 510(k) Submission Details - K921511

510(k) Number K921511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date June 17, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 49
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K921511.
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
K944535 · Prima, Inc. · Nov 1994
AIRWAY CONNECTOR WITH FLEX TUBE
K942392 · Mallinckrodt Medical · Aug 1994
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993
FLEX-ELBOW
K912652 · Vital Signs, Inc. · Oct 1991
AEROVENT
K894969 · Monaghan Medical Corp. · Oct 1989
BAXTER BAFFLED TEE ADAPTER
K895014 · Baxter Healthcare Corp · Oct 1989