Cleared Traditional

K911895 - QUALTEX SUTURE BOOTIES

K911895 is an FDA 510(k) clearance for QUALTEX SUTURE BOOTIES, manufactured by Deroyal Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K911895 · Deroyal Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
9d
Days
Class 1
Risk

K911895 is an FDA 510(k) clearance for the QUALTEX SUTURE BOOTIES. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on May 8, 1991 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K911895

510(k) Number K911895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date May 08, 1991
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - MDM Instrument, Manual, Surgical, General Use

All 12
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K911895.
ORC ENDOSCOPIC INSTRUMENT HOLDER
K930399 · O.R. Concepts, Inc. · Feb 1993
LACERATION REPAIR TRAY
K921988 · Cypress Medical Products, Ltd. · Nov 1992
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
K911369 · Deroyal Industries, Inc. · May 1991
YANKAUER SUCTION DEVICE
K905478 · Medovations, Inc. · Dec 1990
SHAVE PREP TRAY
K855132 · Dynarex Corp. · Jan 1986
THE EQUALIZER
K801328 · The Anspach Effort, Inc. · Jun 1980