Cleared Traditional

K951420 - INCASE EXTENSIBLE BAG--NON-STERILE

K951420 is an FDA 510(k) clearance for INCASE EXTENSIBLE BAG--NON-STERILE, manufactured by Alpha Surgical, Inc.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K951420 · Alpha Surgical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
73d
Days
Class 1
Risk

K951420 is an FDA 510(k) clearance for the INCASE EXTENSIBLE BAG--NON-STERILE. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Alpha Surgical, Inc. (Eau Claire, US). The FDA issued a Cleared decision on June 8, 1995 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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 Alpha Surgical, Inc. devices

FDA 510(k) Submission Details - K951420

510(k) Number K951420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date June 08, 1995
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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 - LYU Accessory, Surgical Apparel

All 16
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K951420.
AMMI MAGNI-GUARD
K961454 · American Medical Mfg., Inc. · Jul 1996
SLOAN STA-DRI PANT PROTECTOR
K945302 · Sloan Corp. · Mar 1996
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K942200 · Thantex Specialties, Inc. · Aug 1995
MAKAR FULL AND HALF FACE SHIELD
K942828 · Instrument Makar, Inc. · Feb 1995
FACE-IT SHIELD
K942022 · Onyx Medical Corp. · Jul 1994
TECNOL SPLASHGUARD
K934842 · Tecnol Medical Products, Inc. · Mar 1994