Cleared Traditional

K102403 - SAM CHEST SEAL WITH VAVLE (FDA 510(k) Clearance)

Also includes:
SAM CHEST SEAL

Class I General & Plastic Surgery device.

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

Submission Details

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
77d slower than avg
Panel avg: 114d · This submission: 191d
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.