Cleared Traditional

K101257 - ADVANCED TRAUMA DRESSING (ATD)

K101257 · Nanosys, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
576d
Days
-
Risk

K101257 is an FDA 510(k) clearance for the ADVANCED TRAUMA DRESSING (ATD). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Nanosys, Inc. (Palo Alto, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 576 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K101257

510(k) Number K101257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2010
Decision Date December 01, 2011
Days to Decision 576 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
461d slower than avg
Panel avg: 115d · This submission: 576d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K101257.
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
K120958 · Hemostasis, LLC · Jul 2012
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
HEMCON HEMOSTATIC GEL
K112215 · Hemcon Medical Technologies Europe, Ltd. · Apr 2012
CLO-SURPLUS P.A.D.
K112961 · Scion Cardio-Vascular, Inc. · Oct 2011
CORELEADER HEMO-PAD MODEL CPII 02030
K102944 · Coreleader Biotech Co., Ltd. · Sep 2011
GUARDACARE
K103641 · Hem Con Medical Technologies, Inc. · Jun 2011
K101257 · ADVANCED TRAUMA DRESSING (ATD)
Download PDF FDA Summary Nanosys, Inc.