Cleared Traditional

K963298 - FIRST AID KIT(S)

K963298 is an FDA 510(k) clearance for FIRST AID KIT(S), manufactured by Vector, Inc.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K963298 · Vector, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
77d
Days
Class 1
Risk

K963298 is an FDA 510(k) clearance for the FIRST AID KIT(S). Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Vector, Inc. (Orchard Park, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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 Vector, Inc. devices

FDA 510(k) Submission Details - K963298

510(k) Number K963298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1996
Decision Date November 06, 1996
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

BYG Device Classification - Class 1, General Controls

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
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 - BYG Mask, Oxygen

All 24
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K963298.
HANS RUDOLPH NASAL CPAP MASK
K962848 · Hans Rudolph, Inc. · Oct 1996
SEAL RING FOR NASAL CPAP
K921499 · Devilbiss Health Care, Inc. · Sep 1992
TRACHEOSTOMY MASK
K913501 · B & F Medical Products, Inc. · Jan 1992
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633 · Salter Labs · Jul 1991
SLEEPAP MASK
K894642 · Medical Industries America, Inc. · Oct 1989
KENDALL CURITY OXYGEN MASK
K892434 · The Kendal Co. · Aug 1989