Cleared Traditional

K990861 - WOUND DRESSING/ABD PAD

K990861 is the FDA 510(k) clearance for WOUND DRESSING/ABD PAD by Hospital Specialty Co.. It is a Class 1 General & Plastic Surgery device (product code NAD) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K990861 · Hospital Specialty Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
27d
Days
Class 1
Risk

K990861 is an FDA 510(k) clearance for the WOUND DRESSING/ABD PAD, MODEL #10810. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Hospital Specialty Co. (Cleveland, US). The FDA issued a Cleared decision on April 12, 1999 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Hospital Specialty Co. devices

Submission Details

510(k) Number K990861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1999
Decision Date April 12, 1999
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 35
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K990861.
WET CHAMBER
K020781 · Kinetic Concepts, Inc. · May 2002
OTOSILK OTOLOGICAL GRAFT DRESSING
K964534 · Boston Medical Products, Inc. · Apr 1997
OTOSILK
K952203 · Boston Medical Products, Inc. · Jul 1995
MEDLINE STERILE GAUZE SPONGES
K930697 · Medline Industries, Inc. · Jun 1993
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc. · Jan 1991
TENSOPLUS LITE
K901378 · Smith & Nephew United, Inc. · Jun 1990