510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040208Substantially Equivalent

Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band

TZ Medical Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040208 is the FDA 510(k) clearance record for NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND, cleared for Tz Medical, Inc. on under FDA product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics). FDA's definition for product code QSY reads: "To temporarily control bleeding and cover external wounds". FDA records list 15 510(k) clearances for Tz Medical, Inc., from to . As of , FDA records show one recall naming K040208.

Clearance record

Decision date
Received
(102 days to decision)
Product code
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Tz Medical, Inc. 7272 SW Durham Rd., #800, Portland OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSY

Trailing 12 months
4 clearances under product code QSY in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QSY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260