Cleared Traditional

K913772 - PRESSURE GUARD

K913772 is an FDA 510(k) clearance for PRESSURE GUARD, manufactured by Beacon Laboratories, Inc.. The device is a Class 2 General & Plastic Surgery device with product code HIF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K913772 · Beacon Laboratories, Inc. · General & Plastic Surgery device
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Nov 1991
Decision
88d
Days
Class 2
Risk

K913772 is an FDA 510(k) clearance for the PRESSURE GUARD. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Beacon Laboratories, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 884.1730 - 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 Beacon Laboratories, Inc. devices

FDA 510(k) Submission Details - K913772

510(k) Number K913772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date November 19, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 - HIF Insufflator, Laparoscopic

All 96
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K913772.
UNIVERSAL GENERAL USE KIT #7-510-16
K914401 · Northgate Technologies, Inc. · Nov 1991
RECIRCULATION KIT #7-510-18
K914402 · Northgate Technologies, Inc. · Nov 1991
GENERAL USE KIT #7-510-20
K914403 · Northgate Technologies, Inc. · Nov 1991
VERRES NEEDLES 5 & 6 INCHES
K911179 · Northgate Technologies, Inc. · Nov 1991
LAPAROSCOPIC INSUFLATION Y TUBING
K911479 · United States Endoscopy Group, Inc. · Apr 1991
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K905481 · Northgate Technologies, Inc. · Mar 1991