Cleared Traditional

K924069 - SURGICO OXYGEN MASK

K924069 is an FDA 510(k) clearance for SURGICO OXYGEN MASK, manufactured by Gujarat Surgico, Ltd.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K924069 · Gujarat Surgico, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
177d
Days
Class 1
Risk

K924069 is an FDA 510(k) clearance for the SURGICO OXYGEN MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Gujarat Surgico, Ltd. (Navrangpura Ahmedabad-380, IN). The FDA issued a Cleared decision on February 4, 1993 after a review of 177 days - an extended review 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: 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 Gujarat Surgico, Ltd. devices

FDA 510(k) Submission Details - K924069

510(k) Number K924069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date February 04, 1993
Days to Decision 177 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 140d · This submission: 177d
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 28
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K924069.
SYSTEM 22 ADULT MASK
K940887 · Medic-Aid , Ltd. · Apr 1994
SYSTEM 22 PAEDIATRIC MASK
K940888 · Medic-Aid , Ltd. · Apr 1994
MEDWAY OXYGEN MASK
K931952 · Medway · Aug 1993
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