Cleared Traditional

K101257 - ADVANCED TRAUMA DRESSING (ATD)

K101257 · Nanosys, Inc. · General & Plastic Surgery device
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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.

View all Nanosys, Inc. devices

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 47
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K101257.
BONDILOXS TOPICAL HEMOSTATIC DRESSING
K132333 · Medtrade Products , Ltd. · Jun 2014
CELOX GAUZE PRO
K113560 · Medtrade Products , Ltd. · Aug 2012
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
CELOX RAPID GAUZE
K110386 · Medtrade Products , Ltd. · May 2011
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
K102965 · Medtrade Products , Ltd. · Dec 2010