Cleared Traditional

K102403 - SAM CHEST SEAL WITH VAVLE

Also marketed or referenced as:
SAM CHEST SEAL

K102403 is an FDA 510(k) clearance for SAM CHEST SEAL WITH VAVLE, manufactured by Sam Medical Products. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K102403 · Sam Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
191d
Days
Class 1
Risk

K102403 is an FDA 510(k) clearance for the SAM CHEST SEAL WITH VAVLE. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Sam Medical Products (Wilsonville, US). The FDA issued a Cleared decision on March 3, 2011 after a review of 191 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sam Medical Products devices

FDA 510(k) Submission Details - K102403

510(k) Number K102403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2010
Decision Date March 03, 2011
Days to Decision 191 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
76d slower than avg
Panel avg: 115d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

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 45
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K102403.
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
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022 · Fraass Survival Systems, Inc. · Aug 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc. · Jan 1991