Cleared Traditional

K072681 - BLOODSTOP HEMOSTATIC GAUZE

Also marketed or referenced as:
IX HEMOSTATIC GAUZE
K072681 · Lifescience Plus, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
42d
Days
-
Risk

K072681 is an FDA 510(k) clearance for the BLOODSTOP HEMOSTATIC GAUZE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Lifescience Plus, Inc. (Mystic, US). The FDA issued a Cleared decision on November 2, 2007 after a review of 42 days - a notably fast clearance cycle.

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: 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 Lifescience Plus, Inc. devices

FDA 510(k) Submission Details - K072681

510(k) Number K072681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date November 02, 2007
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
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 91
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K072681.
MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
K072486 · Hem Con Medical Technologies, Inc. · Aug 2008
MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET
K080097 · Medtrade Products , Ltd. · Jul 2008
MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT
K072328 · Medtrade Products , Ltd. · Dec 2007
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
K070520 · Biolife, LLC · Oct 2007
QUIKCLOT EX
K072474 · Z-Medica Corporation · Oct 2007
BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
K071578 · Lifescience Plus, Inc. · Sep 2007