Cleared Traditional

K761199 - AIRWAY PRESSURE MONITOR

K761199 is an FDA 510(k) clearance for AIRWAY PRESSURE MONITOR, manufactured by Draeger Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K761199 · Draeger Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1977
Decision
84d
Days
Class 2
Risk

K761199 is an FDA 510(k) clearance for the AIRWAY PRESSURE MONITOR. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1977 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - the FDA general and plastic surgery 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K761199

510(k) Number K761199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1976
Decision Date February 28, 1977
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAP Suture, Nonabsorbable, Silk

All 18
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K761199.
VISITEC PRECISE-POINT
K942234 · Visitec Co. · Jul 1994
NONABSORBABLE SILK SURGICAL SUTURE
K904478 · United States Surgical, A Division of Tyco Healthc · Nov 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
K904891 · United States Surgical, A Division of Tyco Healthc · Nov 1990
NEEDLES AND SUTURES, SILK & NYLON
K760158 · Alcon Laboratories · Aug 1976